Browse Warning Letters By Subject

A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 0-9

5 5 Panel Drug Screen A Acidified Dairy Products/Misbranded Acidified Food Products Acidified Foods Acidified Foods/Adulterated Acidified Foods/Emergency Permit Control/Adulterated Acidified Foods/Emergency Permit Control/Adulterated/GMP for Mfr Packing Holding Food Acidified Foods/Emergency Permit Control/Adulterated/Misbranded Acidified Foods/Import Not Held for FDA Inspection/Misbranded/Adulterated Acidified Processing Plant/Adulterated Acidity Levels ACIS/Clinical Claims/Misbranded/Adulterated/Premarket Notification Procedure Action Potential Stimulation Therapy Device/Promotional Claims/Lacks Premarket Approval/Misbranded Activa Tremor Control System/Promotional Claims/Class III Device/Lacks Premarket Approval Active Pharmaceutical Ingredient Active Pharmaceutical Ingredient Manufacturing Facility/Adulterated Active Pharmaceutical Ingredient Manufacturing Facility/Adulterated/cGMP Active Pharmaceutical Ingredient Mfr Facility/Adulterated/Manufacturing Processing Packaging etc. Active Pharmaceutical Ingredient Mfr Facility/Adulterated/Manufacturing, Processing, Packaging, etc. Active Pharmaceutical Ingredient/Adulterated Active Pharmaceutical Ingredient/Adulterated/FMP's Manufacturing Processing Packing etc. Active Pharmaceutical Ingredient/Adulterated/FMP's Manufacturing, Processing, Packing, etc. Active Pharmaceutical Ingredient/Adulterated/GMP's Manufacturing Processing Packing Active Pharmaceutical Ingredient/Adulterated/GMP's Manufacturing, Processing, Packing Active Pharmaceutical Ingredients, Repackaging, Relabeling/Adulterated Active Pharmaceutical Ingredients/Misbranded Acutron Mentor TENS device/Lacks Premarket Approval/Misbranded AdatoSil 5000/Misbranded/Adulterated/Lacks Premarket Approval Adotomed Silicone/Lacks Premarket Approval/Misbranded/Adulterated Adulterated Animal Drugs/Misbranded Adulterated Food Adulterated Seafood HACCP Adultered Devices Adultered Food Products/Listeria Monocytogenes Type I (L. mono) Adverse Drug Experience Reporting Requirements Advertising/Post-Marketing Reporting Requirements Airline Catering Facility Airline Catering Facility/Control of Communicable Diseases and Interstate Conveyance Sanitation Airline Catering Facility/Insanitary Conditions Airline Commissary/Control of Communicable Diseases and Interstate Conveyance Sanitation Airline Lavatory Services Airline Meals Airline Support Facility Airline Support Facility/Interstate Conveyance Sanitation Airline Waste Service Airline Waste Service and Airline Watering Points Facilities Airline Watering Point and Lavatory Service Operation/Interstate Conveyance Sanitation Airline-Catering Kitchen Deficiencies Airling Catering Facility/Interstate Conveyance Sanitation Alfalfa Sprout/Insanitary Conditions/Adulterated Allergenic Extract/Finished Pharmaceuticals/Manufacturing/Holding & Processing Allergenic Extracts/Good Manufacturing Practices/Biologicals Standards Products AlloMatrix/Lacks Approved Premarket Application/Adulterated Alpha Betic Multi-Vitamin Supplement with Alpha Lipoic Acid/Labeling/Lacks NDA/Misbranded Amino Acid/Dietary Supplements/Labeling AMO PhacoFlex II Intraocular Lens/Promotional Claims/Lacks Application for PMA/Misbranded etc. AMO PhacoFlex II Intraocular Lens/Promotional Claims/Lacks Application for PMA/Misbranded, etc. Analytical Methodology Analytical Testing Aneu Vysion Assay/Lacks Premarket Approval/Misbranded Animal Antibiotic/Lacks "May Proceed Notice" or "Release Notice" Animal Drug Products/Wound Dressing Products Animal Drug/Adulterated Animal Drug/Regitration & Listing Animal Drugs Animal Drugs/Misbranded Animal Feed Manufacturing Operation Animal Food Processing Plant/Processing of Low Acid Canned Foods (LACF) Animal Food/Misbranded/Labeling Animal Protein Feed/Equine/Adulterated Animal Protein Prohibited in Ruminant Feed Animal Proteins Prohibeted in Ruminant Feed Animal Proteins Prohibited in Ruminant Feed Animal Proteins Prohibited in Ruminant Feed/Adulterated Animal Proteins Prohibited in Ruminant Feed/Adulterated/GMP for Medicated Feeds Animal Proteins Prohibited in Ruminant Feed/Adulterated/Misbranded Animal Proteins Prohibited in Ruminant Feed/Feed Mill Animal Proteins Prohibited in Ruminant Feed/Misbranded Animal Sale for Slaughter as Food/Adulterated Animal Sale for Slaughter as Food/Feed/Drug/adulterated/ Animals for Sale for Slaughter as Food/Adulterated Animals for sale for slaughter/Adulterated Aniridia Implants/Adulterated/Lack Application for Premarket Approval Anti-reflux Z-Stent/Misbranded/Adulterated Anticoagulant Drug Products/Lacks NDA ANDA IND/Labeling/Device-Adulterated Anticoagulant Drug Products/Lacks NDA, ANDA, IND/Labeling/Device-Adulterated Anticuries Drug Products for OTC Use/Misbranded API Products Applicable Standards and Requirements/Vaccines Approved Labeling Aquaculture Drugs/GMP in Manufacturing, Processing, Packing, or Holding & Finished Pharmaceuticals Arbor Test Microscope/Misbranded/Adulterated Arizona Rx Stress Relief Elixir/Misbranded/Labeling Artificial Insemination Aid/Unapproved New Animal Drug Application Aseptic Parenteral Manufacturing/cGMP Violations AutoCyte PREP System/Promotional Claims Avocado Pulp/Not Held Intact for Inspection Avocados/Lacks Ayla's Formula 777/Lacks NDA/Misbranded/Labeling False Misleading Ayla's Formula 777/Lacks NDA/Misbranded/Labeling False, Misleading B Backflow Prevention Device BAK Interbody Fusion System/Promotional Claims Baked Food Baked Goods/Lacks "May Proceed Notice" or "Release Notice" Bean Sprout/Insanitary Conditions/Adulterated Beltfish/Lacks "May Proceed Notice" or "Release Notice" Berman Resusi CPR Mask/Lacks Premarket Approval Betadrene-SR/Lacks Approved New Drug Application Beverage/New Drug Application/Labeling Bio-Oxy Bio-Oxygen Bioelectrical Discharger/Misbranded/Lacks Premarket Approval Bioengineered Human Replacement Dermis [skin] Bioequivalence Biologic Diagnostic Standards/Device Laboratory Practice Biologic Drugs Biological Product Establishment Standard/Adulterated Biological Products Standards Biological Products/GMP for Fisnished Pharmaceuticals Biologics Biologics Laboratory Testing Biologics laboratory testing Quality System Regulation Biologics laboratory testing, Quality System Regulation Biologics License/Adulterated Biologics/Production and Process Controls Biopsy Forceps Bioresearch Monitoring Information System Bioresearch Monitoring Program/IRB BioScan/Promotional Claims Blend Sampling Stability/GMP Blood & Blood Components Blood & Blood Products/Adulterated Blood Bags Blood Band & Laboratory/CGMP/Blood & Blood Component Regulations Blood Bank Blood Bank Software Blood Bank/CGMP/Finished Pharmaceuticals Blood Bank/GMP for Blood & Blood Components Blood Bank/Standard Operating Procedures Blood Products Blood Products / Standard Operating Procedures Blood Products/Adulterated Blood Products/Facilities/Production and Process Controls/Records & Reports Blood Products/Lacks Approved License for Interstate Commerce Blood Products/Physicians Certification Blood Products/Standard Operating Procedures (SOP) Body Gel/Lacks "May Proceed Notice" or "Release Notice" Body Scan 2010 VLD-100/Promotional Material/False and Misleading etc. Body Scan 2010, VLD-100/Promotional Material/False and Misleading, etc. Body Vibes System I & II Bone Density Mineral Assessment System BonePlast/Lacks Premarket Notification BOTOX/False & Misleading Material/Misbranded Bottle Water Operation Bottled Drinking Water Brazilian Black Pepper/Not Held Intact Bulk Drug Repackaging Bulk Drug Repacking & Distribution Facility/Active Pharmaceutical Ingredients/Animal Drug Bulk Drug Substances Bulk Pharmaceutical Chemical/CGMP Bulk Pharmaceutical Chemicals Bus Services C Candy/Lacks "May Proceed" or "Release Notice" Candy/misbranded/adulterated Canned Food Importation Canned Foods Canned Tuna/Seafood HACCP/Adulterated Canned Tune/Entry Not Held Intact Carbonated Beverages/Lacks "May Proceed Notice" or "Release Notice" Cardiac Catherization Monitoring System CASEC Powder Protein Supplement/Labeling/Misbranded Category II - Type A Medicated Articles/New Animal Drug/Adulterated Catering Facilities Catheters & Vascular Access Ports Cattle / Food Caviar Repackaging CD Player Combination Systems/Lacks "May Proceed Notice" or "Release Notice" CeeOn Edge/Lacks Approved Premarket Application/Adulterated/Misbranded Celebrex/Promotiona Activities Materials/False Misleading Etc. Celebrex/Promotiona Activities, Materials/False, Misleading, Etc. Certain Drugs Accord New Drug Status through Rulemaking Procedures/Guaifenesin Certain Drugs Accorded New Drug Status through Rulemaking Procedures/Guaifenesin CFR Deviations CFR Deviations/Bakery Products CGMP CGMP Active Pharmaceutical Ingredient CGMP Deviations CGMP Deviations/Additional Standards for Human Blood and Blood Products/Adulterated CGMP Deviations/Manufacture of Blood Grouping Reagents (BCR) CGMP Deviations/Silver Nitrate Applicators CGMP For Blood & Blood Components CGMP for Blood & Blood Components/Adulterated CGMP for Blood & Components/Additional Standards for Human Blood & Blood Products/Adulterated CGMP for Blood & Components/General Biological Products Standards/Adulterated CGMP for Blood and Blood components/Records and Reports CGMP for Deviations/Adulterated CGMP for Drugs/Manufacture Processing Packing Holding/Adulterated CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated CGMP for Drugs/Manufacture, Processing, Packing, Holding/Adulterated/Misbranded CGMP for Finished Pharmaceutical CGMP for Finished Pharmaceutical/Adulterated CGMP for Finished Pharmaceuticals/Adulterated CGMP for Finished Pharmaceuticals/Adulterated/Misbranded CGMP for Finished Pharmaceuticals/CGMP in Manufacturing, Processing, Packing, or Holding/Adulterated CGMP for Finished Pharmaceuticals/Compressed Oxygen USP/Adulterated CGMP for Finished Pharmaceuticals/Deviations/Adulterated CGMP for Finished Pharmaceuticals/Drug and Cosmetic Manufacturing Facility/Adulterated CGMP for Finished Pharmaceuticals/Drugs Repacking Facility/Adulterated CGMP for Finished Pharmaceuticals/Human Drug Manufacturing Facility/Adulterated CGMP for Finished Pharmaceuticals/Medical Gas Transfilling Operation/Adulterated CGMP for Finished Pharmaceuticals/Medical Oxygen CGMP for Finished Pharmaceuticals/Medical Oxygen/Adulterated CGMP for Finished Pharmaceuticals/Misbranded/Adulterated CGMP for Finished Pharmaceuticals/OTC Drug & Dietary Supplement/Adulterated CGMP for Finished Pharmaceuticals/OTC Drug Manufacturing/Adulterated CGMP for Finished Pharmaceuticals/Postmarketing Adverse Drug Experience/Adulterated CGMP for Finished Pharmceuticals/Oxygen Filling Facility/Adulterated CGMP for Finished Products/Compressed, Liquid Oxygen/Adulterated CGMP for Food/Seafood HACCP CGMP for Foods/HACCP CGMP for Foods/Juice HACCP/Adulterated/Misbranded CGMP for Foods/Seafood HACCP CGMP for Foods/Seafood HACCP/Adulterated CGMP for Foods/Seafood HACCP/Adulterated/Misbranded CGMP for Licensed Medicated Feeds/Adulterated CGMP For Manfacturing, Processing, Packing, Storage & Holding/Adulterated CGMP for Manufacturing, Packing or Holding Human Food/Control of Communicable Diseases/Adulterated CGMP for Manufacturing, Packing, Holding Food/Seafood HACCP/Adulterated CGMP For Manufacturing, Packing, or Holding Human Food CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Insanitary Conditions CGMP For Manufacturing, Packing, or Holding Human Food/Adulterated/Misbranded/Insanitary Conditions CGMP For Manufacturing, Packing, Storage or Installation/Adulterated CGMP For Manufacturing, Packing, Storage or Installation/Adulterated/Misbranded CGMP For Medical Device Report/Adulterated CGMP for Medical Device Reporting/Adulterated CGMP for Medical Devices Reporting/Adulterated/Misbranded CGMP for Medical Devices/Adulterated CGMP for Medical Devices/Lacks Premarket Approval Application/Adulterated CGMP for Medical Devices/Medical Device Reporting/Adulterated CGMP for Medical Devices/Medical Device Reporting/Misbranded CGMP for Medical Devices/QS/Adulterated CGMP for Medical Devices/QSR/Adulterated/Misbranded CGMP for Medicated Feeds/Adulterated CGMP for Medicated Feeds/Unapproved New Animal Drug/Adulterated CGMP for Oxygen/Manufacturing, processing, packing, storage & holding/Adulterated CGMP for Processing & Bottling of Bottled Drinking Water/Adulterated CGMP in Finished Pharmaceuticals/Lacks Registration/Adulterated/Misbranded CGMP in Manufacturing, Packing, Holding Food/Food Labeling/Misbranded CGMP in Manufacturing, Packing, or Holding Food for Human Consumption/Seafood HACCP/Adulterated CGMP in Manufacturing, Packing, or Holding Human Food/Adulterated CGMP in Manufacturing, Packing, or Holding Human Food/Seafood HACCP/Adulterated/Misbranded CGMP in Manufacturing, Processing, Packing or Holding/CGMP for Finished Pharmaceuticals/Adulterated CGMP in Mfg, Packing, or Holding Human Food/Processing & Bottling of Bottled Drinking Water CGMP Manufacture of Licensed Biological Vaccine Products/Bulk Drug Substances/Components CGMP Manufacture, Processing, Packing or Holding of Human Drugs/Adulterated CGMP Manufacture, Processing, Packing or Holding/Adulterated CGMP Manufacturer, Processsing, Packing, Holding Drugs/Devices/Adulterated CGMP Manufacturing, Packing, or Holding Human Food/Adulterated CGMP Medical Device Reporting/Adulterated/Misbranded CGMP Packing or Holding Human Food/Insanitary Conditions/Sprouts CGMP Regulation for Finished Pharmaceuticals/Adulterated CGMP Regulation For Food/Adulterated CGMP Regulation/Violations CGMP Regulations for Blood & Blood Components/CGMP for Finished Pharmaceuticals CGMP Regulations for Blood and Blood Components CGMP Regulations for Finished Pharmaceuticals/Adulterated CGMP Regulations for Finished Pharmaceuticals/Lacks New Drug Application/Misbranded CGMP Regulations for Foods/Seafood (HACCP) CGMP regulations for Medicated Feeds/New Animal Drug for Use in Animal Feeds regulation/adulterated CGMP Regulations For Medicated Feeds/New Animal Drug/Adulterated CGMP Regulations/Sunscreen Products CGMP Requirement for Food Manufacturing/Adulterated CGMP Requirement for Medical Devices/Lacks Premarket Approval Application/Adulterated CGMP Requirement of the Quality System Regulation for Medical Device CGMP Requirement of the Quality System Regulation for Medical Devices/Adulterated CGMP requirements for medical devices/adulterated CGMP Requirements for Medical Devices/Adulterated CGMP Requirements for medical devices/adulterated CGMP Requirements for Medical Devices/Quality System Regulation CGMP Requirements for Medical Devices/Quality System Regulations/Adulterated CGMP Requirements For Medicated Feeds/Adulterated CGMP Requirements for Medicated Feeds/Animal Proteins Prohibited in Ruminant Feed CGMP Requirements for the Quality System Regulation/Adulterated/Misbranded CGMP requirements for the Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded CGMP Requirements in the Manufacturing of Drugs/Adulterated CGMP Requirements of Medical Device Reporting/Misbranded/Adulterated CGMP Requirements of the Quality System Regulations/Adulterated CGMP Requirements of the Quality System Regulations/Adulterated/Misbranded CGMP Requirements of the Quality System Regulations/First Aid Kits & Sterile Kits/Adulterated CGMP, Packing, or Holding Human Food/Insanitary Conditions/Sprouts CGMP/Active Pharmaceutical Ingredient Manufacturing Facility CGMP/Active Pharmaceutical Ingredients CGMP/Active Pharmaceutical Ingredients/Adulterated CGMP/Adulterated cGMP/Aseptic Drug Manufacturing CGMP/Blood & Blood Components CGMP/Deviations For Food Manufacturers/Adulterated CGMP/Deviations/Adulterated CGMP/Drug/Deviations/Adulterated CGMP/Finished Pharmaceuticals/Adulterated cGMP/Finished Pharmaceutical/Oxygen Repacking Facility/Adulterated CGMP/Finished Pharmaceuticals CGMP/Finished Pharmaceuticals/Adulterated CGMP/Finished Pharmaceuticals/Oxygen Transfilling Facility/Adulterated cGMP/Finished Pharmaceuticals/Veterinary Drug Manufacturing Facility CGMP/Food Labeling/New Drug CGMP/Foods/Insanitary Conditions CGMP/IVR Manufacturing CGMP/Lack Approved New Drug Application/Adulterated/Misbranded CGMP/Liquid Oxygen/Adulterated CGMP/Manufacturing Facility/Active Pharmaceutical Ingredient CGMP/Manufacturing Packing & Holding Human Food CGMP/Manufacturing Packing & Holding Human Food/Misbranded CGMP/Manufacturing, Packing & Holding Human Food CGMP/Medical Device & Pharmaceutical Manufacturing Facility CGMP/Medical Gases/Adulterated CGMP/Medical Oxygen/Adulterated CGMP/Medicated Feeds/Adulterated CGMP/Misbranded CGMP/New Animal Drug Application/Adulterated/Misbranded CGMP/Otc Drug Products/Adulterated CGMP/Oxygen Compressed/Adulterated CGMP/Pharmaceutical Manufacturing Facility CGMP/Pharmacy Compounding/Insanitary Condition/Adulterated/Misbranded CGMP/Prepared, Packed, or held under insanitary Conditions/Adulterated CGMP/Processing & Bottling of Bottled Drinking Water Regulations/Adulterated CGMP/QS/Adulterated/Misbranded CGMP/QSR/Adulterated CGMP/QSR/Adulterated/Manufacture/Packing/Storage/Installation CGMP/QSR/Adulterated/Misbranded CGMP/QSR/Lacks Premarket Approval Application/Medical Device Reporting Regulation CGMP/QSR/Manufacture/Packing/Storage/Installation CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated CGMP/QSR/Manufacture/Packing/Storage/Installation/Adulterated/Misbranded CGMP/QSR/Medical Device Reporting/Adulterated CGMP/QSR/Medical Device Reporting/Adulterated/Misbranded CGMP/QSR/Medical Device Reporting/Misbranded CGMP/QSR/Medical Device/Adulterated CGMP/QSR/Medical Devices/Adulterated CGMP/QSR/Medical Devices/Adulterated/Misbranded CGMP/Quality System/Adulterated CGMP/Requirements for Medical Devices/QSR/Adulterated Cheese & Milk Products/Manufactured from Raw Milk Containing Penicillin & Residue Cheese & Related Cheese Products/Misbranded Cheese Products/Raw Milk/Sulfamethazine Contamination Cheese/Lacks "May Proceed Notice" or "Release Notice" Cheeses and Related Cheese Products /Misbranded Chimal/Starlee Skin Shields/Lack Approved New Drug Application Chinese and Indian Eggplant/Lacks "May Proceed Notice" or "Release Notice" Cholesterx/Lacks Approved New Drug Application/Misbranded Cholestrol Support Capsules/Unapproved New Drug Application/Misbranded Choo-Hooves Pressed Sticks/Adulterated Food/Pet Foods Manufacturer CII Bionic Ear/Lacks Approved Premarket Approval/Adulterated Cipor HC Otic/Current Good Manufacturing Practices/Laboratory Controls Circumvention of Import Alert/Misleading Labeling/Misbranded Clindamycin Hydrochloride Clinical Investigator Clinical Investigator (Sponsor) Clinical Investigator/Sponsor Colon Hydrotherapy Color Additive Undeclared/Misbranded Color Additive/Adulterated Color Additive/Adulterated/Misbranded Color Additives Certification Color Monitors/Not Available for FDA Examination Communicable Diseases and Interstate Conveyance Compact Disc Players Compounding Human, Veterinary Drugs/Misbranded Compounding Veterinary Drug/GMP for Finished Pharmaceuticals/Misbranded/Adulterated Compounding Veterinary Drugs/Extralabel Drug Use/Compounded Human Drugs/Contamination/Sub-potency Compressed Oxygen Computer Systems Condylox Gel/Advertising and Labeling Contact Lenses Contact Lenses/Labeling/Adulterated/Misbranded Contact Lenses/Lacks "May Proceed Notice" or "Release Notice" Contact Lenses/Lacks Premarket Approval/Misbranded Contaminated Fatty Acid Residue in Animal Feed/GMP Manufacturing/Adulterated Contaminated Water / Federal Regulations Interstate Conveyance Content Uniformity Testing/Good Manufacturing Practices Control of Communicable Disease Control of Communicable Disease and Interstate Conveyance Sanitation Control of Communicable Disease and Interstate Conveyance Sanitation/Adulterated Control of Communicable Diseases and Interstate Conveyance Regulations Violations Control of Communicable Diseases and Interstate Conveyance Sanitation Control of Communicable Diseases and Interstate Conveyance Sanitation/Airline Caterign Facility Control of Communicable Diseases/Adulterated Control of Communicable Diseases/Interstate Conveyance Sanitation Conveyance Sanitation Regulations Coronary Stent System Cosmetic Raw Material/Lacks "May Proceed Notice" or "Release Notice" Cosmetics Cosmetics/Lacks "May Proceed Notice" or "Release Notice" Cosmetics/Shampoo Cosmetics/Skin-Cap Shampoo Crab Meat/Lacks "May Proceed Notice" or "Notice of Release" Crabmeat Processing Current Good Manuafacturing Practice for Medical Devices/Adulterated/Misbranded Current Good Manufacturing Practice Current Good Manufacturing Practice Current Good Manufacturing Practice for Medical Devices Current Good Manufacturing Practice (CGMP) requirements for medical devices/adulterated Current Good Manufacturing Practice (CGMP) Adulterated/Misbranded Current Good Manufacturing Practice (cGMP) regulations for Blood and Blood Components/adulterated Current Good Manufacturing Practice for Blood & Blood Products/Plasmapheresis Facility Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded Current Good Manufacturing Practice for Finished Pharmaceuticals/Misbranded/Adulterated Current Good Manufacturing Practice for Medical Devices/Adulterated Current Good Manufacturing Practice for Medical Devices/Adulterated/Misbranded Current Good Manufacturing Practice for Medicated Feed/Adulterated Current Good Manufacturing Practice for Medicated Feeds/Adulterated Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food/Adulterated Current Good Manufacturing Practice in Manufacturing Packing or Holding Human Food/Sprouts Current Good Manufacturing Practice in manufacturing, packing, or holding human food Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food/Adulterated Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food/Sprouts Current Good Manufacturing Practice in Manufacturing, Packing, or Holding/Adulterated Current Good Manufacturing Practice of Active Pharmaceutical Ingredients /Adulterated Current Good Manufacturing Practice Regulation for Finished Pharmaceuticals Current Good Manufacturing Practice Regulation for Foods/Seafood HACCP/Adulterated Current Good Manufacturing Practice Regulation/Adulterated Current Good Manufacturing Practice Regulations for Human Foods/Adulterated Current Good Manufacturing Practice Regulations for Medical Gases Current Good Manufacturing Practice Regulations for Medical Gases/Adulterated Current Good Manufacturing Practice Regulations for Medicated Feeds/Adulterated Current Good Manufacturing Practice Regulations/Oxygen USP/Adulterated Current Good Manufacturing Practice Regulations/Steril & Non-Sterile Prodcuts Current Good Manufacturing Practice Requirements for Foods Current Good Manufacturing Practice Requirements for Foods/Adulterated Current Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated Current Good Manufacturing Practice Requirements for Medical Device Reporting (MDR) Current Good Manufacturing Practice Requirements for Medical Devices/Quality System Regulation Current Good Manufacturing Practice/Adulterated Current Good Manufacturing Practice/adulterated/misbranded Current Good Manufacturing Practice/Adulterated/Misbranded Current Good Manufacturing Practice/Medical Device Report Regulation/Adulterated Current Good Manufacturing Practices Current Good Manufacturing Practices for Blood & Components/Adulterated Current Good Manufacturing Practices for Blood and Blood Components Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated Current Good Manufacturing Practices for Medicated Feeds Current Good Manufacturing Practices for Sterile Pharmaceuticals Current Good Manufacturing Practices Regulation for Foods/Juice HACCP/Adulterated Current Good Manufacturing Practices Regulations for Blood & Blood Components/Adulterated Current Good Manufacturing Practices Requirements for Medical Devices/Adulterated Current Good Manufacturing Practices/Active Pharmaceutical Ingredient Current Good Manufacturing Practices/Active Pharmaceutical Ingredient Manufacturing Facility Current Good Manufacturing Practices/Active Pharmaceuticals Ingredient/Adulterated Current Good Manufacturing Practices/Bulk Pharmaceutical Chemical Current Good Manufacturing Pratice Requirements for Foods/Seafood HACCP Current Good Manufacturing Requirements for Medical Devices/Adulterated Current Good Manufacuring Practice Reuirement for Food Manufacuring/Adulterated Current Good Mfg Practice Regulation/Adulterated/Misbranded Current Good Mfg Practice Regulations/Adulterated Current Manufacturing Practice in Manufacturing Packing or Holding Human Food/Sprouts Current Manufacturing Practice in Manufacturing, Packing, or Holding Human Food/Sprouts Custom Sterile Procedure Kits Cuurent Good Manufacturing Practice/Adulterated/Misbranded Cyropreserved Heart Valves/Quality System Regulation/Adulterated D Daily Elixir First Aid Mixture/Misbranded/Adulterated Dairy and Feeder Cattle Operations Dairy Operation/Adulterated Dairy Products Dairy Products / CGMP Dairy/Adulterated/Illegal Drug Residue Dairy/Illegal Drug Residue/Adulterated Data Management System DDMAC DDMAC Promotional DDMAC/Advertisement is false or misleading DDMAC/Promotional Claims False & Misleading/Misbranded Dear Abbokinase Customer Letter/Omission False Misleading Statements Dear Abbokinase Customer Letter/Omission, False, Misleading Statements Deionized Water System Dental Device Systems/Quality System Regulation/Adulterated Dental Devices Dental Implants Dental Lasers / Quality System Regulations Dermacoat Hand Cream/Lacks New Drug Application Dermal Tone/Lacks Premarket Approval/Misbranded Detoxification Program Deviation from applicable Standard Operating Procedures Deviation from Good Manufacturing Practice Deviation from Good Manufacturing Practice / Medical Devices Deviation/Adulterated Deviations from CGMP for Finished Pharmaceuticals Deviations from Code of Federal Regulations Deviations From Low Acid Canned Food Regulation/Adulterated Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products Device /Lacks Marketing Clearance Approval/Adulterated/Misbranded Device Labeling/Promotional Claims/Misbranded Device Labeling/Quality System Regulation/Misbranded/Adulterated Device Lacks Marketing Clearance Approval/Adulterated/Misbranded Device Quality System Regulations (QSR)/Pro Soft Cuff Device Quality System Requirement (QSR) Device/Adulterated Device/Lacks Approved Premarket Application/Adulterated/Misbranded Device/Lacks Approved/Misbranded Device/Lacks Premarket Approval Application/Adulterated/Misbranded Device/Lacks Premarket Approval Notification/Adulterated Device/Ultrasound Equipment Device/User Facility Reporting Requirements/Misbranded Devices Devices Correction & Removal/Class II Violative Products Devices/ActiTrac Monitor Display & Analysis Software & Sleep Scoring Program Devices/ActiTrac Monitor, Display & Analysis Software, & Sleep Scoring Program Devices/Acupressure Bands Devices/Adapters Devices/Adcon-L Devices/anti-HIV-1 Western Blot Devices/Automatic Collimator Devices/Backflow prevention Devices/Balloon Therapy Devices/Biopsy Needles Devices/Bipolar Forceps Devices/Blood Glucose Monitoring System Devices/Blood Lancets Devices/Blood Pressure Monitoring System Devices/Bloodlines Devices/Bone Densitometers Devices/Booker Box Devices/Breast Implants Devices/Breast Pump Kit Devices/BURNFREE Products Devices/Cardiopulmonary Monitoring System Devices/Carotid Shunts Devices/Catheters Devices/Cervical Plate Systems Devices/Colonic Irrigation Systems Devices/Colostomy Rods & Ileostomy/Colostemy/Urostomy Bags Devices/Compex 2 Devices/Computer Software Devices/Computer Systems Devices/Contact Lenses Devices/Cordis' S.M.A.R.T. Stent Devices/Corn and Callus Removers Devices/Corneo Gage Ultrasonic Pachometer Devices/Crystal Stimulator Devices/Defibrillators Devices/Dental Devices/Dental Instruments Devices/Dental X-ray Systems Devices/Dermabraders Devices/Diagnostic Systems Devices/Dialysis equipment Devices/Ear Candles Devices/Earplanes Devices/ECG Monitors Devices/ElecDT & VacuPulls Devices/Electrocardiographic Amplifiers Devices/Electrodes Devices/Electrometers Dosemeters Devices/Electronic Muscle Stimulator Devices/Electrosurgical Probes Devices/Endoscope and Endotherapy Systems Devices/Endoscopes and Bipolar Forceps Devices/Endosseous Implants Devices/Examination Gloves Devices/Eye Center Devices/Eye Cups Devices/Finger Sensors Devices/Flowmeters Devices/Gastrostomy Kits Devices/Glasses Devices/Glucose Tolerance Test Beverages Devices/H-Wave Muscle Stimulator Devices/Health Energizer Devices/Hearing Aid Devices/Hearing Aids Devices/Heating Pads Devices/Hemodialysis Systems Devices/HIV Test Kit Devices/Hospital Beds Devices/Humidifiers & Vaporizers Devices/Hypo-Allergenic Air Machine Devices/Imaging Kit Devices/Implants Devices/Implementing Regulations Devices/In Vitro Products Devices/Infusion Sets Devices/Injection System Devices/InstaTrak System Devices/Instrument Covers & surgical Drapes Devices/Intraocular Lenses Devices/Iodine Implantable Seeds Devices/Irrigation pump Devices/Lacks Premarket Approval Devices/Laser Eye Devices/Laser Products Devices/Laser Systems Devices/Latex Gloves Devices/Magnetic Belts and Straps Devices/Magnetic Resonance Nuclear Medicine & Computer Tomography Devices/Magnetic Resonance, Nuclear Medicine & Computer Tomography Devices/Massage Therapy System Devices/MaxiSound Devices/Medical Gas Analyzers Devices/Medical Laser Devices/Micro Reader III and HyPrep Plus Devices/Microcannulas & Aspirators Devices/Microhematocrit Centrifuge Devices/Microvascular Anastomotic System Devices/Monitoring System Devices/MRX Microplate Readers Devices/Needle Systems Devices/NeedleSafe Devices/Not Held for Inspection Devices/Octyldent Devices/Ophthalmic Diagnostic Units Devices/Orthopedic Implants Devices/Orthopedic Instruments Devices/Oximeter Finger Sensor & Cables Devices/Ozone Generators Devices/Paste Products Devices/Patient Beds Devices/Patient Monitors Devices/Patient Monitors Software Devices/Penile Tumescence Monitors Devices/Phototherapy Systems Devices/Plasma Collection Systems Devices/Plasma Separators Devices/Pneumatic Compression Devices Devices/Podiatric Devices/Powder Coating of Endosseous & Orthopedic Implants Devices/Precision Current Source Devices/Pregnancy Test Devices/Protheses Devices/Pulmonary Artery Catheters Devices/Quality System Regulation Devices/Reagent Strips Devices/Rejuveness Silicone Devices/RepAide Non-Rebreathing Mask and Valve Devices/Reprocessing Devices/Resuscitator & Pressure Valve Devices/Resuscitators Devices/Saliva Ejectors Devices/Sanitation Devices/Scanner Devices/Sculpting System Devices/Secure 3000 Beds Devices/Sharps Containers Devices/Shortwave Daithermy Device Devices/Shotwave Diathermy Device Devices/Skin Refrigerant Devices/Spinal Implants Devices/SpineCATH Electorthermal Arthroscopy System Devices/Sponges Devices/Stair-Trac Stair-Porter and Evacu-Trac Devices/Stair-Trac, Stair-Porter and Evacu-Trac Devices/Sterile Bandages Devices/Sterile insufflation tubing sets Devices/Sterile Products Devices/Sunlamps Devices/Surgical and Dental Instruments Devices/Surgical Instruments Devices/Syringes Devices/Tectonic Magnets Devices/Teleradiology System Devices/Test Kits Devices/Test Strips Devices/Therapeutic Plasma Exchnge Devices/Tomography Devices/Toothbrush Systems Devices/Tremor Control Systems Devices/Trocar Devices/Ultrameters Devices/Ultrasound Probes Devices/Utrasonic Therapy Devices/Wound Dressing Devices/Wound Dressings Devices/Wound Gel & Dressing Devices/X-ray Equipment Devices/X-ray Systems Devices/Xknife Stereotactic Radiosurgery System Diagnostic Standards/Laboratory Practices Diagnostic Ultrasound Equipment/Lacks Premarket Approval/Misbranded Diagnostic X-ray Equipment Diagnostic X-ray Equipment (Performance Standards) Diapro, Inc. (dba Diapro USA Inc), San Francisco District Office, Natural PentosePlus Dietary Supplement Contract Manufacturing Facility/Adulterated/Misbranded Dietary Supplement Labeling Regulations/Misbranded Dietary Supplement Lableing/False & Misleading Claims/Misbranded Dietary Supplement Regulations/Misbranded Dietary Supplement/Adulterated Dietary Supplement/Labeling False and Misleading/Misbranded Dietary Supplement/Labeling/Adulterated Dietary Supplement/Labeling/False & Misleading Claims/Misbranded Dietary Supplement/Labeling/Misbranded Dietary Supplement/Plantain Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded Dietary Supplements Dietary Supplements/Adulterated/Misbranded Dietary Supplements/Adulterated/Misbranded/Labeling Dietary Supplements/Food Labeling/Misbranded Dietary Supplements/Food/New Drug/Adulterated/Misbranded Dietary Supplements/Labeling/Misbranded Digoxin Tablets/Good Manufacturing Practices for Finished Pharmaceuticals Diovan/False & Misleading Promotional Claims Diprivan Infectable Emulsion/Misbranded/False or Misleading Promotional Labeling Disposable Infusion Pump Kit/Qaulity System Regulation/Adulterated Diveces/In-vitro Diagnostic Biologicals Donor Tissue Dried Fig Spread/Lacks Dried Shrimp/Food Labeling Drug Component Ingredients Drug File Card/False & Misleading Claims/Misbranded Drug in Edible Tissue/Extralabel Use/Adulterated Drug Labeling/Misbranded Drug Labeling/Promotional Claims/Misbranded Drug Manufacturing Facilities/CMP Regulations for Finished Pharmaceuticals Drug Manufacturing Facility(OTC)/cGMP Drug Manufacturing Operations/CGMP deviations Drug Marketing/Unapproved Prescription Drugs Drug Product/Antifungal Cream & Nail Revitalizer Drug Product/Hand Sanitizer Drug Product/New Drug Application Drug Product/Penicillin Repackaging Drug Product/Project U-2000 Drug Product/Rubbing Oil Drug Product/Smoking Deterrent Drug Products Drug Products / CGMP Drug Products/Advertising Drug Products/Alcohol Drug Products/Anti-Microbial Hand Soap Drug Products/Antifungal Solution & Wash Drug Products/Antimicrobial Soap Drug Products/Aquaprin Drug Products/BeneFin & SkinAnswer Drug Products/CFR Deviations Drug Products/CGMP Deviations Drug Products/Chelo Garde & Chelo Plus Drug Products/Cosmetic Claims Drug Products/Deodorant Spray Drug Products/Esspro 7 Drug Products/Friatroy Drug Products/GMP Drug Products/HEPA Filters Drug Products/Heparin & Saline Syringes Drug Products/Imorphint Sulfate Tablets Drug Products/Labeling Drug Products/Laxatives Drug Products/Manufacture & Distribution Deviations Drug Products/MaxAlert Drug Products/Megestrol Acetate Tablets Drug Products/Ointment & Salution Drug Products/Ophthalmic Solutions Drug Products/OTC Acne Drugs Drug Products/Pediculicides Drug Products/Promotional Material Drug Products/Repackaging Operations/CGMP Drug Products/Riboflavin Drug Products/Schedule III and IV Drugs Drug Products/Skin Creams Drug Products/SPV-30 Herbal Extract Drug Products/Standard Operating Procedures (SOP) Drug Products/Sterility Drug Products/Swimmer's Ear Drops Drug Products/Testing Drug Products/Theophylline Drug Products/Therapeutic Claims Drug Products/Topical Aspirin Drug Products/Topical Ointment Drug Products/Topical Salve/Manufacturing Processing Packing Storage or Holding Drug Products/Topical Salve/Manufacturing, Processing, Packing, Storage or Holding Drug Products/Weight Loss Drug Repacking and Relabeling Drug Residue Edible Animal Tissue/Adulterated Drug Residue Edible Tissue/Adulterated Drug Residue in Animal Tissue/Adulterated Drug Residue in Edible Animal Tissue/Adulterated Drug Residue in Edible Tissue/Adulerated Drug Residue in Edible Tissue/Adulterated Drug Residues/Edible Tissues/Adulterated Drug Testing Laboratory/GMP Regulations/Laboratory Controls/Records & Rpts/Personnel Qualifications Drug/Lacks Approved Application Dynacin Dynamometers/Quality System Regulation for Medical Devices/Adulterated/Misbranded E E-Steth/Lacks Application for Premarket Approval/Adulterated/Misbranded Edible Tissue/Adulterated Edible Tissue/Insanitary Conditions/Adulterated Edible Tissues/Adulterated Edible Tissues/Adulterated/Labeling Electroencephalograph Devices Electronic Product Radiation Control Electronic Product Radiation Control/Performance Standards for Microwave Ovens Electronic Product Radiation Control/Premarket Notification Requirements/Adulterated/Misbranded Electronic Product Radiation Control/Television Products Manufacturing Electrophysiology Catheters Electrosurgical Probes Electrosurgical Systems/Lack Premarket Norification/Quality System Regulation Energy Drinks/Failure to Hold an Entry Intact Entry Not Held Intact/Misbranded Entry/Lacks "May Proceed" or "Release Notice" Ephedra/Ma Huang/New Drug Equipment Cleaning Valisation/Microbial Specifications/Purity Stability Testing Equipment Cleaning Valisation/Microbial Specifications/Purity, Stability Testing ES1 Therapeutic Massager/Lacks Premarket Approbal/Misbranded eScreen Drugs of Abuse/Lacks Premarket Approval Esophageal Probes Esophageal Stethoscopes / CGMP Ethylene Oxide Sterilization EverCLR/Lacks Approved New Drug Application Excimer Laser System/Adulterated Extra Label Drug Use/Misbranded Extralabel Drug /Approved Labeling/Adulterated Extralabel Drug Use In Animals Extralabel Drug Use in Animals/Adulterated Extralabel Drug Use in Animals/Adulterated/Misbranded Extralabel Drug use in Animals/Adultered Extralabel Drug Use in animals/Drug Residue in edible Tissue/Adulterated Extralabel Drug Use in Animals/Illegal Drug Residue in Edible Tissue Extralabel Drug Use in Animals/Illegal Drug Residue/Adulterated Extralabel Drug Use in Animals/Misbranded Extralabel Drug Use in Medicated Feed/Adulterated Extralabel Drug Use/Adulterated Extralabel Drug Use/Adulterated/New Animal Drug Extralabel Drug Use/Illegal Drug Residue/Adulterated Extralabel Drug Use/Phenylbutazone/Unaproved New Animal Drug/Adulterated Extralabel use regulations/adulterated Extralabel Use/Drug Residue in Edible Tissue/Adulterated Eye Bank/Donor Screening Testing/Procedures & Records Eye Bank/Donor Screening, Testing/Procedures & Records Eye Lubricant F Failure to Comply with Device Quality System Regulation Failure to Observe Code of Federal Regulations Failure to observe Standard Operating Procedures Failure to Observe Standard Operating Procedures False & Misleading Claims/Misbranded False & Misleading Claims/New Drug/Misbranded False and Misleading Advertising Fast Pack Total PSA Assay/Misbranded/Lacks Premarket Approval FD&C Yellow No. 5/Undeclared Color Additive/Adulterated/Misbranded FDA / Federal Food Drug and Cosmetic Act Violations Federal Food, Drug and Cosmetic Act Violations Federal Food, Drug and Cosmetic Act/Misbranded Federal Food, Drug, and Cosmetic Act Violations Federal Food, Drug, and Cosmetic Act Violations/Misleading Federal Laser Product Performance Standard/Laser Light Show Federal Performance Standard for Laser Products Federal Performance Standard for Laser Products/GLP Green Laser Pointer Federal Performance Standard for Microwave Ovens Federal Performance Standard for Microwave Ovens/Electronic Product Radiation Controls Federal Performance Standard for Sunlamp Products Federal Performance Standard for Sunlamp Products/Misbranded Feed Mill/Animal Proteins Prohibited in Ruminant Feed/Adulterated Ferris Pain Pad & Wrap/Adulterated/Lacks Approved Pre Market Approval Application Fertility Awareness Kit-The Lens/Lacks Premarket Notification/Misbranded/Adulterated Finished Coffee Products/Misbranded Finished Pharmaceuticals Finished Pharmaceuticals/Oxygen Repackaging Facility/CGMP First Option Uterine Cryoblation Therapy/Lacks Premarket Approval/Misbranded Fish & Fishery Products Regulation/HACCP/Adulterated Fish and Fishery Product/HACCP Fish Maw/Import Alert/Contains Filth Elements Fluorescent Pattern Monitors Folic Acid Products/Lacks Approved New Drug Application/Misbranded Food Food / Animal for Slaughter Food / Candy Food / Cheese Products Food / Cooked Shrimp Food / Fish Food / Frozen Shrimp Food / Fruits Food / Fruits and Vegetables Food / Insanitary Conditions Food / Juice Food / Mushrooms Food / Swine Food / Tuna Food / Vegetables Food Additive Permitted in Feed, Drinking Water of Animals/Unsafe Food Additive/Adulterated Food Additive/Adulterated Food Additive/Adulterated/Misbranded Food Additive/Ammoniated Cottonseed Food Drinks Food for Human Consumption/Misleading Containers/Misbranded Food Handling & Sanitation Practice/Bacteria Contamination/Adulterated Food Handling & Sanitation Practice/Bacterial Contamination/Adulterated Food Import/Not held for FDA examination Food Import/Not Held for FDA Release Food Labeling Food Labeling Misbranded Food Labeling Regulation Food Labeling Requirements/Misbranded Food Labeling Warning & Notice Statements/Orange Juice/Misbranded Food Labeling/Adulterated Food Labeling/Adulterated/Misbranded Food Labeling/Apple Cider/Misbranded Food Labeling/Beverage Food Labeling/Canned Tomato Products/Misbranded Food Labeling/Carbolite/Misbranded Food Labeling/Cheese products/Misbranded Food Labeling/Dietary Supplements/Misbranded Food Labeling/False & Misleading Claims/Adulterated/Misbranded Food Labeling/False & Misleading Claims/Misbranded Food Labeling/False & Misleading/Claims Misbranded Food Labeling/False & Misleading/Misbranded Food Labeling/Flavored Coffees Food Labeling/Food Additive Misbranded Food Labeling/Food Manufacturing Facility Food Labeling/Fresh Apple Slices/Misbranded Food Labeling/Fruit Joy Blue Rasberry Drink Food Labeling/Fruit Juice Manufacturing Facility Food Labeling/Gelatin and Vanilla Custard Products Food Labeling/GMP Food Labeling/GMP Packing, Holding Food/Adulterated/Misbranded Food Labeling/Good Manufacturing Practice for Manufacturing, Packing or Holding Human Food Food Labeling/Graeter's Famous French Pot Ice Cream/Misbranded Food Labeling/Insanitary Conditions/Adulterated/Misbranded Food Labeling/Juice Products Food Labeling/Lacks Approved New Drug Application/Misbranded Food Labeling/Lacks New Drug Application/Misbranded Food Labeling/Listing Color Additive/Adulterated/Misbranded Food Labeling/Misbranded Food Labeling/Misbranded/Acidified Foods Food Labeling/Misbranded/Seafood HACCP/GMP for Manufacturer, Packing, Holding Food Food Labeling/New Drug,Misbranded Food Labeling/New Drug/Misbranded Food Labeling/New Drugs/Misbranded Food Labeling/NexCite Dietary Supplement/Misbranded Food Labeling/Prgnancy-6 Food Labeling/Processing & Standard Identity for Bottled Drinking Water/Adulterated/Misbranded Food Labeling/Seafood HACCP/Adulterated/Misbranded Food Labeling/Seafood HACCP/Misbranded/Adulterated Food Labeling/Seafood/HACCP Food Labeling/Spirulina Spirals & Low Fat Fruity Booty Food Labeling/Undeclared Ingredients/Known Food Allergies/Misbranded Food Labeling/Undeclared Ingredients/Misbranded Food Labeling/Undeclared Sulfites/Misbranded Food Labiling/GMP for Acidified Foods/Misbranded/Adulterated Food Processing Food Processing Violations Food Product Manufacturing Facitity/Labeling Food Products Food Products Not Held for Inspection Food Products Storage/Insanitary Conditions Food Products/Import Not Held for Inspection Food Sanitation and Inspection Service Food Standards/Cheese and Related Products/Misbranded Food Storage Warehouse/Insanitary Conditions/Adulterated Food Warehouse/Insanitary Conditions/Food Products/Adulterated Food Water and Water Disposal /Federal Regulations for Interstate Conveyances Food, Water and Water Disposal /Federal Regulations for Interstate Conveyances Food/Adulterated Food/Apple Products Food/Bread Food/Candy Food/Canned Food/Canned Corn Food/Canned Tuna Shipment Food/Cattle Food/Cattle/Adulterated Food/Caviar Food/Chocolate Eggs Food/Crabmeat Food/Dairy Cow Food/Dairy/Adulterated Food/Egg Noodles Food/Enzymes Food/Extralabel Drug Use in Animals/Adulterated Food/Fish Food/Fish Roe Food/Fishcake Product Labeling Food/Fresh Fruit Food/Hearts of Palm Food/Held Under Insanitary Conditions/Adulterated Food/Held Under Insanitary Conditions/Illegal Drug Residue/Adulterated Food/Horse Food/Human Food/Infant Formula Food/Insanitary Practices/Adulterated Food/Juice Products Food/Labeling Food/Lemons and Bananas Food/May Proceed Notice or Notice of Release Food/Nuts Food/Pickles Food/Raisins Food/Raw Milk Food/Sanitation Food/Seafood Food/Seasoning Food/Shipment Food/Shrimp Food/Sprouts & Noodles Food/Tamarind Candy Food/Tofu Food/Veal Foodstuffs & Cheese Shipment Foodstuffs/Lacks "May Proceed Notice" or "Release Notice" Forticel Products/New Drug/Labeling/Misbranded French Yogurt Cheese/Food Labeling/Cheese & Cheese Related Products Fresh Alaskan Halibut Shipment/Lacks "May Proceed Notice" or "Release Notice" Fresh and Frozen Scallops/Lacks "May Proceed Notice" or "Notice of Release" Fresh Coriander and Fresh Avocado/Lacks "May Proceed Notice" or "Release notice" Fresh Dolphin / Mahi-Mahi Fresh Eggplants & Squash/Entry Not Held Intact Fresh Grouper/Lacks "May Proceed Notice" or "Release Notice" Fresh Lettuce/Lacks "May Proceed" or "Release Notice" Fresh Swordfish/Entry Intact Pending Fresh Whole Salmon/Lacks "May Proceed Notice" or "Release Notice" Frozen Flounder and Sardines Frozen Mackerel Fillets/Lacks "May Proceed" or "Release Notice" Fruit Beverage Manufacturing Plant G GBL (Gamma-Butyrolactone) GEDA PLUs & SURETE/Lacks New Drug Application/Misbranded Gene Therapy Glass Bead Dry Heat Sterilizer/Lacks Premarket Approval GLP GLP (Good Laboratory Practices) GLP for Non-Clinical Laboratory Studies GLP Regulations GLP/Bioresearch Monitoring Program GLP/Bioresearch Monitoring Program/Investigational drugs Glucosamine Sulfate & Nasal Decongestant Products/Lacks Approved NDA/Misbranded/Labeling GMP Finished Pharmaceuticals/Postmarketing/Reporting Adverse Drug Experiences/Adulterated GMP for Acidified Foods/Food Labeling/Misbranded GMP for Blood & Blood Components GMP for Blood & Blood Components/Adulterated GMP for Blood & Blood Components/Collection of Blood GMP for Blood & Blood Components/Finished Pharmaceuticals GMP for Blood & Blood Components/General Biological Standards GMP for Blood & Blood Components/Records & Reports GMP for Blood & Blood Products GMP for Blood & Blood Products/Adulterated GMP for Blood & Blood Products/Records & Reports/Adulterated GMP for Blood and Blood Components/GMP for Finished Pharmaceuticals/Adulterated GMP for Blood and Blood Products/Quality System Regulation GMP for Blood and Bood Components/Adverse Reaction Reports GMP for Deviations/Adulterated/Misbranded GMP for Finished Pharmaceuticals GMP for Finished Pharmaceuticals (Active Pharmaceutical Ingredient)/Adulterated GMP for Finished Pharmaceuticals, Veterinary Drug/Adulterated GMP for Finished Pharmaceuticals/Adulterated GMP for Finished Pharmaceuticals/Biologicals/Reporting of Errors/Changes to Approved Application GMP for Finished Pharmaceuticals/Biologics Establishment Standards Licensing GMP for Finished Pharmaceuticals/Biologics Licensing GMP for Finished Pharmaceuticals/Drug Repackaging/Adulterated GMP for Finished Pharmaceuticals/Gas & Liquid Medical Oxygen/Adulterated GMP for Finished Pharmaceuticals/GMP for Blood & Blood Components GMP for Finished Pharmaceuticals/Manufacture & Distribution/Adulterated/Misbranded GMP for Finished Pharmaceuticals/Oxygen USP/Adulterated GMP for Finished Pharmaceuticals/Prescription & Over-the-Counter Products GMP for Finished Pharmaceuticals/Reporting Biological Product Deviations GMP for Finished Pharmaceuticals/Unapproved New Animal Drug/Adulterated/Misbranded GMP for Finished Products/Biologics/Establishment Licensing GMP for Food/Food Labeling/Misbranded/Adulterated GMP for Foods/Lacks HACCP Plan/Misbranded GMP for Low-Acid Canned Foods/Acidified Foods/Emergency Permit Control Regulations/Adulterated GMP for Manufacturing, Packing, Holding Food/Seafood HACCP GMP for Medical Devices/QSR/Adulterated GMP for Medical Devices/QSR/Medical Device Reporting Procedures/Adulterated GMP for Mfr Processing Packing Holding Drugs/Biological Products GMP for Mfr Processing Packing Holding Drugs/Reporting Biological Products Deviations GMP for Mfr, Packing, Holding Food GMP for Mfr, Processing, Packing, Holding Drugs/Biological Products GMP for Mfr, Processing, Packing, Holding Drugs/Reporting Biological Products Deviations GMP for the Quality system Regulation/CGMP for Finished Pharmaceuticals/Adulterated GMP in Manufacturing, Packing, Holding Food/Adulterated GMP in Manufacturing Packing, Holding Food/Adulterated GMP in Manufacturing, Packing, Holding Human Food/Adulterated GMP in Manufacturing, Packing, Holding Human Food/Insanitary Conditions/Adulterated GMP in Manufacturing, Packing, Holding Human Food/Insanitary Practices GMP in Manufacturing, Packing, or Holding Human Food/Interstate Conveyance Regulations/Adulterated GMP in Manufacturing,Packing, or Holding Human Food/Interstate Conveyance Regulations GMP in Mfr, Processing, Packing, Holding Drugs/GMP for Finished Pharmaceuticals/Adulterated GMP Manufacturer, Processing, Packing, Holding Drugs/Adulterated GMP Medical Device Reporting/Adulterated/Misbranded GMP Mfr, Packing, Holding Food/Misbranded/Adulterated GMP Mfr, Processing, Packing, Holding Drugs/GMP for Finished Pharmaceuticals/Adulterated/Misbranded GMP of Manufacturing of Bulk Products/Adulterated GMP Regulation for Finished Pharmaceutical/Lacks Approved Drug Application/Adulterated/Misbranded GMP Regulations for Foods/Food Labeling/Misbranded GMP Regulations/Seafood HACCP/Frozen Shrimp/Adulterated GMP Requirement/Quality System Regulations/Medical Device Reporting GMP Requirements for Quality System Regulation/Dental Products/Adulterated GMP Requirements for the Quality System Regulation/Adulterated GMP's for Blood, Blood Components/Finished Pharmaceuticals GMP/Oxygen and Nitrogen Gases/Adulterated GMPfor Finished Pharmaceuticals/Biological Establishment Licensing/Sterility Good Laboratory Practice (GLP) Regulations Good Laboratory Practices Good Laboratory Practices/Sponsor/Monitor/Contract Research Organization Good Manufacting Practices for Blood and Components Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated Good Manufacturing Practice for Finished Pharmaceuticals/Veterinary Drug Manufacturing Facility Good Manufacturing Practice for Medical Devices Regulation/Quality System/Adulterated Good Manufacturing Practice for Medical Devices Regulations Deviations/Anesthesia Machines Good Manufacturing Practice for Medicated Feeds/Adulterated Good Manufacturing Practice Regulaitons for Finished Pharmaceutical/Ophthalmic Drug Products Good Manufacturing Practice Regulation for Finishes Pharmaceuticals/Drug Manufacturing Facility Good Manufacturing Practice Regulation for Medicated Feeds/Medicated Feed Mill/Adulterated Good Manufacturing Practice Regulations for Blood and Blood Components Good Manufacturing Practice Regulations for Foods/Seafood HACCP Good Manufacturing Practice Regulations for Human Foods/Adulterated Good Manufacturing Practice Regulations for Human Foods/adultered Good Manufacturing Practice Requirement for Foods/Seafood HACCP/Adulterated Good Manufacturing Practice Requirement for the Quality System Regulation/Adulterated Good Manufacturing Practice requirements for foods/Adulterated Good Manufacturing Practice Requirements for Foods/Seafood HACCP/Adulterated Good Manufacturing Practices / Quality System Regulations Good Manufacturing Practices Deviations Good Manufacturing Practices for Acidified Foods/Adulterated Good Manufacturing Practices for Acidified Foods/Emergency Permit Control Regulations Good Manufacturing Practices for Active Pharmaceutical Ingredient Good Manufacturing Practices for Blood & Blood Components Good Manufacturing Practices for Blood & Blood Components/Adulterated Good Manufacturing Practices for Blood and Blood Products Good Manufacturing Practices for Finished Pharmaceutical Regulations/Adulterated Good Manufacturing Practices for Finished Pharmaceuticals Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated Good Manufacturing Practices for Finished Pharmaceuticals/Aseptic Drug Manufacturing/Adulterated Good Manufacturing Practices for Finished Pharmaceuticals/Biological Products General Provisions Good Manufacturing Practices for Finished Pharmaceuticals/Mfr Processing etc. Good Manufacturing Practices for Finished Pharmaceuticals/Mfr, Processing, etc. Good Manufacturing Practices for Finished Pharmaceuticals/Veterinary Drug Manufacturing Facility Good Manufacturing Practices for Finished Products/Adulterated Good Manufacturing Practices for Food Processing/Acidified Foods Good Manufacturing Practices for Food/Adulterated/Insanitary Conditions Good Manufacturing Practices Regulations for Food/Seafood HACCP Good Manufacturing Practices Violation/Finished Pharmaceuticals Good Manufacturing Practices Violations Good Manufacturing Practices/Active Pharmaceutical Ingredients/Adulterated Good Manufacturing Practices/Biologicals Good Manufacturing Practices/Drug Products Manufactured Good Manufacturing Practices/Epinphrine and Meperidine HCl injections Good Manufacturing Practices/Finished Pharmaceuticals Manufacturers Processing Packing etc. Good Manufacturing Practices/Finished Pharmaceuticals, Manufacturers, Processing, Packing, etc. Good Manufacturing Practices/Finished Pharmaceuticals/Mfring Processing Packing etc/Adulterated Good Manufacturing Practices/Finished Pharmaceuticals/Mfring, Processing, Packing, etc/Adulterated Good Manufacturing Practices/Food & Beverage Services Good Manufacturing Practices/Sprout Growing Facility Good Manufacturing Practices/Unlicensed Hospital Blood Bank for Blood and Blood Components Good Manufacturing Processing Packing Holding/Finished Pharmaceuticals/Adulterated Good Manufacturing Processing, Packing, Holding/Finished Pharmaceuticals/Adulterated Good Manufactuting Practices for Finished Pharmaceuticals/Biologicals Physical Establishment Etc. Good Manufactuting Practices for Finished Pharmaceuticals/Biologicals Physical Establishment, Etc. Grape Juice/Lacks "May Proceed" or "Release Notice" Grapefriut/Oranges/Lacks "May Proceed Notice" or "Release Notice" Guidelines for State Licensing of Wholesale Prescription Drug Distributors H Healing Herbs of China/Labeling/Misbranded Health and Safety Violations Heart Pumps/Quality System Regulation/Adulterated Heart Rate Monitor Hema-Strip HIV-1/2 Test Kit/Lacks Investigational Device Exemption/Export Listing Violation Hema-Strip HIV-1/2 Test Kit/Lacks Investigational Device Exemption/Export, Listing Violation Hemodialysis Catheters Hemodialysis Concentrate Solutions Hemodialysis Devices Hemodialysis Water Purification Systems/Quality System Regulation/Adulterated Herbal Products Herpetrol Coated Tablets HGH Support/Lacks Approved New Drug Application/Promotional Claims/Labeling/Misbranded High Density Polyethylene Bottles HIV 1 + 2 Test Kits/Lacks Premarket Approval/Export Regulations/Listing Requirements/Adulterated HIV Test Kits/Lacks Premarket Approval/Export Violations Hollow Fiber Hemodialyzers Horse Buyer/Dealer/New Animal Drug/Adulterated/Insanitary Conditions Hospital Blood Bank Human Cells, Tissues & Cellular Products Human Drug Repacking Facility/cGMP Human Issue Intended for Transplantation Human Prescription Drugs Sale and Distribution for Veterinary Purposes Human Tissue Bank Human Tissue for Transplantation/Quality System Regulation/Adulterated Human Tissue Intended for Transplantation Human Tissue Intended for Transplantation/Procedures & Records Human Tissue Intended for Transportation Human Tissue Intended for Transportation/Donor Testing Screening Human Veterinary Pharmaceutical Manufacturing Facility/CGMP/Finished Pharmaceuticals Human, Veterinary Pharmaceutical Manufacturing Facility/CGMP/Finished Pharmaceuticals Humidifiers & Vaporizers/Quality System Regulation for Medical Devices/Adulterated Hyalgan/Lacks Premarket Approval/Adulterated/Misbranded Hydralazine Hydrochloride Hylasine Gel/Promotional Material/Lacks Approved Application for Premarket Approval/Misbranded Hyperbaric Chambers/Premarket Clearance Hyperbaric Chambers/Quality System Regulation/Adulterated HyperTec Oyster Hybrid & Chambers/Lacks Premarket Approval/Not Substantially Equivalent HyperTec Oyster, Hybrid, & Chambers/Lacks Premarket Approval/Not Substantially Equivalent I Illegal Canadian Drug Importation Illegal Drug Residue Illegal Drug Residue /Adulterated Illegal Drug Residue Animal Tissue/Adulterated Illegal Drug Residue Animal Tissue/Extra-Label Drug Use/Adulterated Illegal Drug Residue Animal Tissue/Extralabel Drug Use in Animals/Adulterated Illegal Drug Residue Animal Tissue/Extralabel Drug Use, Animals/Adulterated Illegal Drug Residue Animal Tissue/Extralabel Use/Adulterated Illegal Drug Residue in animal Tissue/Adulterated Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated Illegal Drug Residue in Animal Tissue/Extralabel Drug Use/Adulterated/Misbranded Illegal Drug Residue in Edible Animal Tissue/Adulterated Illegal Drug Residue in Edible Tissue/Extralabel Drug Use/Adulterated Illegal Drug Residue, Animal Tissue/Adulterated Illegal Drug Residue, Animal Tissue/Adulterated/Extra Label Drug Use Illegal Drug Residue, Animal Tissue/Adultered Illegal Drug Residue, Animal Tissue/Extra Label Drug Use Illegal Drug Residue/Adulterated Illegal Drug Residue/Adulterated/Misbranded Illegal Drug Residue/Animal Tissue/Adulterated Illegal Drug Residue/Animal Tissue/Extra Label Drug Use/Adulterated Illegal Drug Residue/Animal Tissue/Extralabel Drug Use/Adulterated Illegal Drug Residue/Edible Tissue/Adulterated Illegal Drug Residue/Extralabel Drug Use/Adulterated Illegal Drug Residues/Adulterated Illegal Drug Tissue Residue Illegal Drug Tissue Residue/Adulterated Illegal Drug Use/Animal Tissue/Extralabel Drug Use/Adulterated Illegal DrugResidue/Animal Tissue/Adulterated Illegal Edible Tissue Residue/Adulterated Illegal Tissue Residue/ Extralabel Drug Use in Animals/Adulterated Illegal Tissue Residue/Adulterated Illegal Tissue Residue/Extra-label Use/Adulterated Illegal Tissue Residue/Extralabel Drug Use in Animals/Adulterated Illegal Tissue Residues/Adulterated Import Detention /Food Import Food Not Held Intact/Substitution of Product Import for Export/Lacks Premarket Approval Import Not Held for FDA Inspection Import Not Held for FDA Inspection/False Import Entry Import Not Held for FDA Inspection/Pesticides/Adulterated Import Products Import Products/Sunglasses Import/Lacks Import/Lacks "May Proceed Notice" or "Release Notice" Import/Lacks "May Proceed" or "May Release" Import/Lacks "May Proceed" or "Release Notice" Import/Lacks May Proceed or Release Notice Import/Not Held Intact Import/Not Held Intact for FDA Inspection Import/Product Substitution/Adulterated/Misbranded Imported Avocado Pulp/Not Held for Inspection Imported Canned Coffee/Entry Not Held Intact Imported Cheese Imported Cheese/Not Held for Inspection Imported Food/Not Available for Inspection Imported peanuts/Not Held for Inspection Importing Requirements/Dried Raising and Dried Apricots In Vitro Diagnostic Analyzers In Vitro Diagnostic Assay In Vitro Diagnostic Kits & Reagents In Vitro Diagnostic Kits/Quality System Regulation In Vitro Diagnostic Kits/Quality System Regulation for Medical Devices/Adulterated In Vitro Diagnostic Products In Vitro Diagnostic Tests/Quality System Regulation/Adulterated In-Vitro Diagnostic Media/Quality System Regulation for Medical Devices/Adulterated In-Vitro Diagnostic Products/Quality System Regulation/Adulterated In-Vitro Diagnostics Inapproved New Drug/False Misleading Labeling Inerstate Commerce/Food/Adulterated Infant Formula/Adulterated/Misbranded Infant Formula/Labeling/Misbranded Infant Formula/Misbranded Infrared Thermometers Infusion Pumps/Quality Systems Regulation Injectable Cytokine Mixture Insanitary Conditions Insanitary Conditions/Adulterated Insanitary Conditions/Adulterated/Animal Protein Prohibited in Ruminant Feed Not Labeled Insanitary Conditions/Adulterated/Misbranded Insanitary Conditions/Backflow Prevention Device Insanitary Conditions/Backflow Prevention Devices Insanitary Conditions/Food Storage Warehouse Insanitary Conditions/Food Storage Warehouse/Adulterated Insanitary Conditions/Food-Storage Warehouse/Adulterated Insanitary Conditions/Motor Vessels Insanitary Conditions/Mung Bean Sprouts Insanitary Conditions/Raw Sprouts/Adulterated Insanitary Conditions/Sprout Production Facility/Adulterated Insanitary Practices & Conditions Instant Drug Test/Adulterated/Misbranded Instant Ramen Noodles and Snacks/Lacks "May Proceed Notice" or "Release Notice" Institutional Review Board Interactive Database Interstate Commerce/Misbranded Interstate Conveyance Sanitation Interstate Conveyance Sanitation Regulation Deficiencies Interstate Conveyance Sanitation Regulation/Misbranded Interstate Conveyance Sanitation Regulations Interstate Conveyance Sanitation regulations/Communicable Diseases/Adulterated Interstate Conveyance Sanitation Regulations/Potable & Non-potable Water Hydrants Interstate Conveyance Sanitation Regulations/Provisional Interstate Conveyance Sanitation/Control of Communicable Disease Interstate Conveyance Sanitation/GMP Mfr, Packing, Holding Food Interstate Conveyance Sanitation/Insanitary Conditions Intraocular Optical Lenses Intraoral Cameras and Accessories Invalid Veterinarian/Cient/Patient Relationship Invalid Veterinarian/Client/Patient Relationship Investigational Device Exemptions Investigational Device Exemptions (Clinical Investigator) Investigational Device Exemptions (Sponsor) Investigational Device Exemptions(Clinical Investigator)/Adulterated Investigational New Animal Drug Sponsor Investigational New Drug Iontophoretic Drug Delivery Systems/Promo.Material/Lacks PMA for use w/Specific Drugs or Drug Use IRB (Institutional Review Board) Irradiated Products IVD Test Kits/Reporting Requirements J Jamica Flowers Jellied Candy/Lacks Joint Replacement Prostheses/Qiality System Regulation Juice HACCP Juice HACCP/Adulterated Juice Products/Labeling unauthorized Health Claims Juice Products/Labeling, unauthorized Health Claims Juice/HACCP/Adulterated Juice/HACCP/Adulterated/Misbranded K King Fish Product/Contaminated w/ Salmonella/Hold Entry Intact/ Klonopin Tablets/Records & Reports/Stability Testing/Etc. Kristopher Chocolate Santa/Food Labeling/Misbranded Kroger Baking Mix/Adultered/Labeling/Misbranded L Labeling Labeling & Promotional Claims Labeling & Promotional Material Labeling & Promotional Materials Labeling / New Drug Application Labeling / Tea Tree Oil Labeling and Promotion Material/Fluidotherapy Units and Traction Machines Labeling and Promotional Violations Labeling Claims Labeling Drug Claims Labeling False & Misleading Labeling, False & Misleading Labeling/Active Ingredients Labeling/Adulterated Labeling/Adulterated/Misbranded Labeling/Aloe Vera Gel Labeling/Amigdalina Labeling/Antiaging Products Labeling/Antisepic Lotion Labeling/Apple Juice Labeling/ARH-RX Oral Capsules Labeling/BIOFREEZE with ILEX Labeling/Cheese Labeling/Cheese Processing Facility/Unsanitary Conditions Labeling/Cookie Products Labeling/Dietary Supplements/CGMP for Finished Pharmaceuticals/Adulterated Labeling/Dietary Supplements/False & Misleading Claims/New Drug Labeling/Dietary Supplements/Promotional Claims False & Misleading/Misbranded Labeling/Dried Geckoes/Product Misrepresentation Labeling/Echinex and Propalmex Labeling/Examination Gloves Labeling/Eye Drops Labeling/False & Misleading Labeling/False & Misleading Claims/Adulterated/Misbranded Labeling/False & Misleading Claims/Misbranded Labeling/False & Misleading Claims/New Drug Labeling/False & Misleading Claims/New Drug/Misbranded Labeling/False & Misleading/Avonex Labeling/Fen-Phen Labeling/First Check Labeling/Food Additive/Misbranded Labeling/Food Coloring Labeling/Food Products Labeling/Frankfurter Products Labeling/Gamma-Butyrolactone Labeling/Gamma-Hydroxybutyrate Labeling/Ginseng Products Labeling/Herbal Tonic Labeling/Honey Labeling/Juice Beverage Products Labeling/Lacks Premarket Notification Labeling/Lemon Juice Labeling/Longevity Labeling/Makeup Labeling/Misbranded Labeling/MSM Eye & Ear Drops Labeling/Natural TrimPatch Labeling/Nature's Gel Labeling/New Animal Drug/Adulterated/Misbranded Labeling/New Animal Drug/New Drug/Dietary Supplements/Misbranded Labeling/New Drug Application Labeling/New Drug/False & Misleading Claims/Misbranded Labeling/New Drug/Misbranded Labeling/Oral & Topical Products Labeling/OTC Drugs Labeling/OTC Human Use/New Drug/Misbranded Labeling/Pain Relieving Gel Labeling/Pelocell Shampoo Labeling/Premarket Notification Procedure/Adulterated/Misbranded Labeling/Promotional Claims False & Misleading Labeling/Promotional Claims False & Misleading Claims/New Drug/Misbranded Labeling/Promotional Claims False & Misleading/Misbranded Labeling/Promotional Claims False & Misleading/Misbranded/Adulterated Labeling/Promotional Claims False & Misleading/New Drug Labeling/Promotional Claims False & Misleading/New Drug/Misbranded Labeling/Repackaging Material Labeling/Roasted Peanuts Labeling/Smoked Salmon Labeling/Softgels Labeling/Spray Formula Labeling/Tanning Accelerators & Sunscreens Labeling/Therapeutic Claims Labeling/Tpros Labeling/Unapproved New Drug/Misbranded Labeling/Undeclared Nuts Nutritional Labeling Labeling/Undeclared Nuts, Nutritional Labeling Labeling/Veterinary Drugs Lachs Approved Biologic License Application Lack Approval Biologics License/Lack Approved New Drug Application/Misbranded Lack Approved New Drug Application/Misbranded Lack Approved Premarket Application/Adulterated/Misbranded Lack Approved Premarket Application/Adulterated/Not Substantially Equivalent Lack Approved Premarket Approval Application/Blue Cap Spray Lack Approved Premarket Clearance/Adulterated/Misbranded Lack Premarket Approval for Promotional Claims Lacks "May Proceed Notice" or "Release Notice" Lacks Application for Premarket Approval IDE/Adulterated Lacks Application for Premarket Approval/IDE Exemption/Lacks Export Authority Lacks Application for Premarket Approval/Misbranded/Not Substantially Equivalent/Adulterated Lacks Application Premarketing Approval/Adulterated/Misbranded Lacks Approved Biologics License Application/New Drug/Use of Ruminant Products Lacks Approved New Drug Application Lacks Approved New Drug Application/Adulterated Lacks Approved New Drug Application/Adulterated/Misbranded Lacks Approved New Drug Application/Labeling/False & Misleading/Misbranded Lacks Approved New Drug Application/Labeling/Misbranded Lacks Approved New Drug Application/Misbranded Lacks Approved Premarket Application/Adulterated Lacks Approved Premarket Application/Adulterated/Misbranded Lacks Approved Premarket Approval Application/Da Vinci Surgical Systemn/Adulterated/Misbranded Lacks Device PreMarket Approval/Device Registration & Listing/Adulterated Lacks IND or Approved NDA/Misbranded/Adulterated Lacks Marketing Approval/Misbranded/Adulterated Lacks Medicated Feed Mill License/New Animal Drug/Adulterated Lacks New Animal Drug Application Lacks New Animal Drug Application/Adulterated Lacks New Drug Application Lacks New Drug Approval /Misbranded Lacks Pre-Market Notification/Quality System Regulation/Adulterated/Misbrandeded Lacks Pre-Marketing Approval/Adulterated/Misbranded Lacks Premarket Approval Application Lacks Premarket Approval Application Adulterated Lacks Premarket Approval Application Misbranded Lacks Premarket Approval Application/Adulterated Lacks Premarket Approval Application/Adulterated/Misbranded Lacks Premarket Approval Application/Misbranded Lacks Premarket Approval Application/Misbranded/Adulterated Lacks Premarket Approval, Investigational Device Exemption/QSR/Misbranded/Adulterated Lacks Premarket Approval/Adulterated Lacks Premarket Approval/Adulterated/Misbranded Lacks Premarket Approval/Gastroenterology-Urology Devices/Misbranded Lacks Premarket Approval/Labeling/Misbranded Lacks Premarket Approval/Misbranded Lacks Premarket Approval/Not Substantially Equivalent/Adulterated Lacks Premarket Approval/Not Substantially Equivalent/Misbranded/Adulterated Lacks Premarket Approval/Product Equivalence Lacks Premarket Approval/QSR/Adulterated/Misbranded Lacks Premarket Approval/QSR/Not Substantially Equivalent/Adulterated/Misbranded Lacks Premarket Approval/Unapproved IDE/Adulterated Lacks Premarket Clearance/Device Registration Listing/Adulterated/Misbranded Lacks Premarket Notification Approval/Adulterated/Misbranded Lacks Premarket Notification/Adulterated Lacks Premarket Notification/Adulterated/Misbranded Lacks Premarket Notification/Misbranded/Adulterated Lacks Ruminant Caution/Medicated Feeds/Adulterated/Misbranded Lacks Submission Product Substantially Equivalent/Misbranded Large and Small Volume Parenteral Drug Manufacturing/cGMP Lasaer / Distance Mesasuring Device Laser Pointers Laser Pointers/Classification Labeling User Information Laser Pointers/Classification Labeling, User Information Laser Product Performance Standard Laser Product Performance Standard/Labeling Laser Product Performance Standards/Laser Light Show/Electronic Product Radiation Control Laser Products / Noncompliance Laser Surgical Instrument/Lacks "May Proceed Notice" or "Release Notice" Laser Therapy Device/Lacks Premarket Approval/Misbranding/Mislabeling Laser Therapy Devices LaserScan LSX Excimer Laser/Promotional Claims/Misbranded Etc./Unapproved Use LaserScan LSX Excimer Laser/Promotional Claims/Misbranded, Etc./Unapproved Use Latex Examination Gloves/Regulatory Problems Lavatory Services Laveling/TRY-Lean Formula 1 & 2 Laxative Products Lean Body Hi-Protein Meal Replacement Bar/Labeling Lettuce/Not Held Intact Life Support Equipment/Adulterated Limb Sleeve Compression Garment/Adulterated/Misbranded Linescan 222 & Sys 107/ Performance Standards for Ionizing Radiation Emitting Products Liquid & Compressed Oxygen Liquid & Gas Oxygen Liquid and Compressed Oxygen Liquid Carbon Dioxide/Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated Liquid Deprenyl Citrate/Misbranding False Misleading Labeling/Personal Importation/Exportation Liquid Deprenyl Citrate/Misbranding False, Misleading Labeling/Personal Importation/Exportation Liquid Medical Oxygen Liquid Medical Oxygen/Adulterated Liquid Medical Oxygen/CGMP for Finished Pharmaceuticals/Adulterated Liquid Nitrogen Liquid Oxygen Liquid Oxygen / CGMP Liquid Oxygen/Adulterated Listing Color Additives Exempt from Certification/Lacks Premarket Application/Adulterated/Misbranded Lite & Spicy Tofu Pate/Labeling Little Sentry Junior Infant Breathing Monitor/Lacks Premarket Approval Lovastatin/Red Yeast Rice Product/Lacks Approved New Drug Application Low Acid Canned Food Regulation/Adulterated Low Acid Canned Foods Low-Acid Canned Foods/Adulterated Low-Acid Canned Foods/Emergency Permit Control/Adulterated Low-Acid Foods/Adulterated Low-Acid Foods/Emergency Permit Control/Adulterated M Magnetic Therapy Devices/Adulterated/Misbranded Mahi Mahi/Import Not Held for Inspection Mammography Quality Standards Mammography Quality Standards Act Mammography Standards Manometers & Stethoscopes/Lacks "May Proceed Notice" or "Release Notice" Manufacturing Facility/Adulterated/Insanitary conditions Manufacturing Facility/Current Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated Manufacturing Facility/GMP/Mnufacture of Active Pharmaceutical Manufacturing/Warehousing Facility/Insanitary Conditions/Adulterated Marketing an unapproved new drug - ergotamine tartrate Marketing Clearance/Conserve PLUS Marketing without NDA/Misbranding Marlin Loins Shipment/Lacks "May Proceed Notice" or "Release Notice" MD 2000 & MD2 therapeutic Massagers/Lacks Premarket Approval/Adulterated/Misbranded Medical Oxygen/CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Medical Device / Body Fluid Pouch Medical Device Corrections and Removals/Infusion Pumps Medical Device Corrections and Removals/Misbranded Medical Device Reporting Medical Device Reporting & Quality System Regulation/Amukin-D Medical Device Reporting (MDR) Regulation Misbranded/Adulterated Medical Device Reporting Regulation/Fetal Vaccuum Extractor Medical Device Reporting Regulation/Misbranded Medical Device Reporting Regulations/Lacks Premarket Notification/Adulterated/Misbranded Medical Device Reporting Regulations/Quality System Regulation/Adulterated/Misbranded Medical Device Reporting/Circumcision Clamps Medical Device Reporting/Misbranded Medical Device Reporting/NCP System/Misbranded Medical Device/CGMP Requirements of Quality System Regulation Medical Device/Lacks Premarket Approval/Adulterated/Misbranded Medical Device/Misleading Statements/Misbranded Medical Devices Medical Devices / [QS] Quality Systems Regulations Medical Devices / [QSRs] Quality System Requirements Deficiencies Medical Devices / CGMP Medical Devices / Premarket Approval Application [PMA] Medical Devices Regulation/Saline Fill Mammary Implants Medical Devices Reports of Correction & Removals Medical Devices/Adulterated/Misbranded Medical Devices/Infusion Pumps Medical Devices/Lack Premarket Approval Medical Devices/Lacks Medication & Device Experience Report/Misbranded Medical Gas Manufacturing Facility Medical Gas Manufacturing/Adulterated Medical Gas Transfilling Operation/Liquid Oxygen Medical Gas/Adulterated Medical Gases / CGMP Medical Gases/Current Good Manufacturing Practice for Finished Pharmaceuticals/Adulterated Medical Image Printers/Quality System Regulation/Adulterated Medical Kits / GMPV Medical Oxygen Medical Oxygen / CGMP Medical Oxygen and Nitrogen Medical Oxygen Transfilling Facility Medical Oxygen Transfilling Facility/CGMP Regulation for Finished Pharmaceuticals/Adulterated Medical Oxygen Transfilling/Adulterated Medical Oxygen/Adulterated Medical Oxygen/Adulterated/Misbranded Medical Oxygen/CGMP for Finished Pharmaceuticals/Adulterated/Misbranded Medical Oxygen/GMP for Manufacture Processing Packing Holding Drugs/Adulterated Medical Oxygen/GMP for Manufacture, Processing, Packing, Holding Drugs/Adulterated Medicated Articles Medicated Feed Manufacturing Facility Medicated Feed Mill Operations/Adulterated Medicated Feed Mill/Adulterated Medicated Feeds Medicated Feeds/Adulterated Medicated Feeds/CGMP Meicated Feeds Metanabol/New Drug/Misbranded Methadone Methamphetamine Hydrochloride/Active Pharmaceutcal Ingredients/Adulterated Microwave Oven Microwave Ovens Migraine Ice/Unpproved Application for Premarket Approval Miracle Wild Yam Cream/Misbranded Mis-Invoiced Products Misbranded/Cheeses Misbranded/Labeling/Unauthoriz ed Health Claims Misbranded/Labeling/Unauthorized Health Claims Misleading Promotional Materials Multi-Sign Monitors & Pulse Oximetry Monitors/Lacks "May Proceed Notice" or "Release Notice" Mung Bean Sprout Processing Operations/Insanitary Conditions/Adulterated Mushroom Dark Soy Sauce/Lacks "May Proceed Notice" or "Release Notice" Mustard Greens/Pesticide Chemical Permethrin N Nail Cure/Lacks Approvad New Drug Application (NDA)/GMP Regulations Narcotic Treatment Program Narcotic Treatment Program Standards Narcotic Treatment Standards Violations Narcotics Treatment Program Standards Nasal Spray Natural Latex Condoms Nature's Plus Ultra-Zyme Tablets/Continued Sale of Recalled Product/Adulterated NDA Fails To Bear Adequate Directions/Misbranded Needle Electrodes New Animal Drug Application New Animal Drug for Use In Feeds/Lacks FDA Medicated Feed Mill License/Adulterated New Animal Drug Product New Animal Drug/Adulterated New Animal Drug/Adulterated/Labeling/Misbranded New Animal Drug/Adulterated/Misbranded New Animal Drug/Drug Residue Edible Tissue/Adulterated New Animal Drug/Extralabel Drug Use/Adulterated New Animal Drug/Held Under Insanitary Conditions/Adulterated New Animal Drug/Illegal Drug Residue/Adulterated New Animal Drug/Tissue Sample/Adulterated New Animal Drugs in Animal Feed/GMP for Animal Feed/Misbranded/Adulterated New Animal Drugs/Extralabel Drug Use in Animals/Adulterated/Misbranded New Animal Drugs/Feeds New Animal Drugs/Misbranded New Drug New Drug (OTC) New Drug Application New Drug Application [NDA] New Drug Listing/Misbranded New Drug, Unapproved New Drug/"Alterations to Illicit Street Drugs" New Drug/Adulterated New Drug/Adulterated/Misbranded New Drug/Adulterated/Misbranded/Unapproved New Drug/Approved Biologics License Application New Drug/Drug Labeling/Misbranded New Drug/False Misleading Labeling New Drug/False Misleading/Labeling/Misbranded New Drug/False Promotional Statements/Misbranded New Drug/False, Misleading Statements/Misbranded New Drug/Food Labeling/Adulterated/Misbranded New Drug/GMP for Finished Pharmaceuticals/Adulterated/Misbranded New Drug/GMP for Finished Pharmaceuticals/GMP for Mfr, Processing, Holding Drugs/Adulterated New Drug/GMP for Finished Pharmaceuticals/Misbranded New Drug/Labeling New Drug/Labeling/False & Misleading Claims New Drug/Labeling/False & Misleading Claims/Misbranded New Drug/Labeling/False Promotional Statements/Misbranded New Drug/Labeling/Misbranded New Drug/Labeling/Misbranded/Adulterated New Drug/Misbranded New Drug/Misbranded/Adulterated New Drug/Nutrition Labeling Dietary Supplements/Misbranded New Drug/Topical Acne/OTC/Misbranded New Drugs New Drugs, Unapproved/Labeling/Misbranded New Drugs/Claims New Drugs/Dietary Supplements/Food Labeling/Misbranded New Drugs/Drug Establishement Registration/Misbranded New Drugs/Food Labeling/Medical Foods/Misbranded New Drugs/Misbranded NewView2 Progressive Addition Contact Lenses/Adulterated/Misbranded Nicotine Lollipops & Lip Balm/New Drug/Misbranded Nicotine Lollipops/New Drug/Misbranded No Premarket Approval/Adulterated/Misbranded Noiselezz Anti-Snoring Mouth Guard/Lacks Premarket Notification/Misbranded Non Sterile Examination Gloves Non Sterile Orthopedic Implants Noni Tahiti/Lacks Approved New Drug Application/Misbranded Noni Tahiti/Lacks Premarket Approval/Misbranded Noodle Manufacturing Facility/Insanitary/Adulterated Not Held Intact for Inspection Notification of Use-Prohibited Classification Numerous Insanitary Conditions Nutrient Supplement Manufacturing Facility Nutrition Labeling Nutrition Labeling of Food/Misbranded O Obstetric/Gynecological Devices Octopus Shipment Off-Label Use OncoScint & ProstaScint One Step Morphine Urine Dipstick Test/Undeclared Medical Device Import OPC-830 Oxygen Conserving Regulator/Adulterated/Misbranded Orange Juice Manufacturing Facility Orange Juice Manufacturing Facility/Adulterated Unpasteurized Juice Orange Juice Manufacturing Facility/Misbranded Labels Orbasone/Lacks Premarket Notification/Labeling/Misbranded OTC Drug Labeling/New Drug/Misbranded OTC Drug Manufacturing Facility/cGMP OTC Drug Products/Dietary Supplements/Misbranded OTC Drug Products/GMP OTC Drug Products/Lacks New Drug Approval/Misbranded OTC Drug Products/Misbranded OTC Drug Repackager/Good Manufacturing Practices OTC Drug Repacking/GMP OTC Drug/Cosmetic/GMP OTC Drugs, Devices/Adulterated/Misbranded OTC Drugs/Adulterated/Misbranded OTC Topical Antimicrobial/Lacks New Drug Application Over the Counter Drug Products Over-the Counter Drug/CGMP for Finished Pharmaceuticals/Adulterated Oxiometers/CGMP/Quality System Regulation/Adulterated Oxycontin/False and Misleading Advertising Oxygen Analyzers Oxygen Repackaging Facility Oxygen Repacking Facility/CGMP/Adulterated Oyster Products/Misbranded/Labeling P Packaging Materials Paragon Swiss Plus Implant System/Promotional Claims/Lacks Approved Pre-market Application Paraite Control/Cydectin Passenger Bus Waste Services Pasta/Not Available for FDA Examination Patient Examination Gloves/Quality System Regulation/Adulterated Pavich Brand Organic Crimson Seedless Grapes/Misbranded/Labeling Perfect Solid Protein Bar/Unapproved Food Additive/Adulterated/Misbranded Performance Standard for Diagnosict X-Ray Equipment Performance Standard for Diagnostic X-ray Equipment Performance Standard for Diagnostic X-Ray Equipment/Notification of Defects Performance Standard for Electronic/Laser Product Performance Standard for Electronic/Laser Products Performance Standard for Ionizing Radiation Emitting Products Performance Standard for Sunlamp Products Performance Standards / Diagnostic X-Ray Equipment Performance Standards for Diagnostic X-ray Equipment Performance Standards for Electronic Products/Microwave & Radio Frequency Emitting Product Performance Standards for Ionizing Radiation Emitting Products Performance Standards for Laser Products Performance Standards for Light Emitting Products Performance Standards for Light Emitting Products/Laser Products Performance Standards for Light-Emitting Prods/Records, Reports, CAP Performance Standards for Light-Emitting Products/Laser Light Show Performance Standards for Microwave & Radio Frequency Emitting Prods/Program Disapproval, Detention Performance Standards for Microwave & Radio Frequency Emitting Products Performance Standards, Light-Emitting Products Performance Standards/Sunlamp Products Phakic Intraocular Lenses/Lacks Premarket Approval/Misbranding Pharmaceutical Ingredients Pharmaceutical Manufacturing Facility/CGMP Pharmaceutical Manufacturing Facility/Finished Pharmaceutical Regulations/cGMP Pharmaceuticals/Not Available for FDA Examination Pharmacy Compounding/Adulterated Pharmacy Compounding/GMP for Finished Pharmaceuticals Pharmacy Compounding/GMP/Adulterated/Drug Labeling, Registration/Misbranded Pharmacy Compounding/Misbrand Pharmacy Compounding/Misbranded Pharmacy Compounding/New Drug/Adulterated/Misbranded Pharmacy Compounding/New Drug/Misbranded Pharmacy Compounding/Unapproved New Drug/Misbranded Phencal PHS Act & Control of Communicable Diseases & Interstate Conveyance Sanitation Violations PHS Act/Violation Pickled Ginger/Unapproved Food Additive/Adulterated Pie Manufacturing Facility Pig Ears Dog Treats/Lacks "May Proceed" or "Release Notice" Plague Vaccine Plasma Donor Regulations Deviations Plasmapheresis Pol'Noni/Promotional Claims/Labeling/Lacks Approved New Drug Application/Misbranded Polenta/Production Processing Controls Acidified Foods etc. Polenta/Production Processing Controls, Acidified Foods, etc. Postmarketing Adverse Drug Experience Postmarketing Adverse Drug Experience (ADE) Reporting Postmarketing Adverse Drug Experience Reporting Requirements Postmarketing Reporting of Adverse Drug Experience Potable Water Potable Water Hydrants/Backflow Prevention Devices/Violations Potassium Bicarbonate/GMP Powder & Gel Wound Dressing Powered Wheelchair/Quality System Regulation Predator Chromium Picolinate & Power Plus Natural Phen-Fen/Lacks New Drug Application/Therapeutic Cl Pregnancy Test Kits/Lack Approved Application for Premarket Approval Premarket Approval Application [PMA] Premarket Approval/Adulterated Premarket Approval/Misbranded Premarket Approval/Misbranded/Adulterated Premarket Notification Procedures/Misbranded/Adulterated Premarket Notification Procedures/Not Substantially Equivalent/Adulterated/Misbranded Premarket Notification/Quality System Regulation/Adulterated Prescription Drug Products Prescription Drug Products/Labeling/Misbranded Prescription Drugs Prescription Non-prescription Drug Repackaging Relabeling/CGMP Prescription Veterinary Drugs Prescription, Non-prescription Drug Repackaging, Relabeling/CGMP Procedural Kits Product Deficiencies Product/Misbranded Production Procedures Production process Controls/Failure to Report Changes to Application Production, process Controls/Failure to Report Changes to Application Progesterone cream/New Drug/Labeling/Misbranded Promotion and Distribution of Unapproved Drugs Promotional & Labeling Violations Promotional Activities Promotional Claims False & Misleading Adulterated/Misbranded Promotional Claims False & Misleading/Adulterated/Misbranded Promotional Claims False & Misleading/Misbranded Promotional Claims False & Misleading/New Drug/Misbranded Promotional Claims False & Misleading/New Drugs Promotional Claims False & Misleading/Unapproved New Drug/Misbranded Promotional Claims/False & Misleading Promotional Claims/False & Misleading/Misbranded Promotional Claims/Misbranded Promotional Claims/New Drug/Misbranded Promotional Labeling Materials/Guidelines System 3000 Promotional Material and Activities Promotional Material/Dupel Iontophoresis Systems and Electrodes Protein Diet Bar/Misbranded/Labeling Protein Fuel Peanut Butter Sports Bar/Misbranded/Labeling Protein Supplements Pulse Oximeter Sensors/Adulterated/Misbranded Pumps (Components)/Lacks Q Qaulity System Regulation/Correction & Removal Regulation/Adulterated/Misbranded QSR for Finished Devices/Adulterated QSR For Medical Device/Adulterated QSR for Medical Devices/Medical Device Reporting/Adulterated QSR for Medical Devices/Medical Device Reporting/Misbranded/Adulterated QSR for Medical Devices/Picture Archiving & Communication Systems Software/Adulterated QSR/Adulterated/Undeclared Ingredient/Misbranded QSR/Lack Premarket Approval/Registration Listing/Adulterated/Misbranded QSR/Lacks Approval Premarket Application/Labeling/Misbranded/Adulterated QSR/Lacks Approved Premarket Application/Misbranded/Adulterated QSR/Lacks Premarket Application/Human Dura Mater Allografts/Adulterated/Misbranded QSR/Lacks Premarket Approval Application/Adulterated/Misbranded QSR/Medical Device Reporting/Adulterated/Device Master Record QSR/Medical Devices/Adulterated QSR/Medical Devices/Adulterated/Misbranded QSR/Medical Devices/Misbranded QSR/Medical Tubing/Adulterated Quality Control & Testing / Radiation Control Quality Control & Testing Program Quality Control and Testing Deficiencies Quality Control Violations Quality regulations/Medical Device Reporting regulations/adulterated/misbranded Quality System Regulations/Full Field Digital Mammography System/Adulterated Quality System Reguation/Adulterated Quality System Regulaion/Trocars & Surgical Instruments Quality System Regulation Quality System Regulation for Medical Device/Model 973 Powered Percussor Quality System Regulation for Medical Devices/Adulterated Quality System Regulation for Medical Devices/Adulterated/Misbranded Quality System Regulation for Medical Devices/Artglass Dental Restorative Material/Adulterated Quality System Regulation for Medical Devices/Colonic Irrigators/Adulterated Quality System Regulation for Medical Devices/Infusion Pumps/Adulterated Quality System Regulation for Medical Devices/Labeling Quality System Regulation for Medical Devices/Patient Lifts & Bath Systems/Adulterated Quality System Regulation for Medical Devices/Premarket Notification Procedures/Adulterated Quality System Regulation Medical Devices/Adulterated Quality System Regulation Violations / Office of Blood Research & Review Quality System Regulation/ Obstetrical & Gynecological Devices Quality System Regulation/510(k) Quality System Regulation/Acupoint Stimulator Quality System Regulation/Adulterated Quality System Regulation/Adulterated/Labeling Quality System Regulation/Adulterated/Medical Device Reporting Quality System Regulation/Adulterated/Medical Device Reporting/Misbranded Quality System Regulation/Adulterated/Misbranded Quality System Regulation/Adultered Quality System Regulation/Adultered/Misbranded Quality System Regulation/Amplatz Thrombectomy Devices Quality System Regulation/Anesthesia Intensive Care Ventilators Incubators & Other Medical Devices Quality System Regulation/Anesthesia, Intensive Care Ventilators, Incubators & Other Medical Devices Quality System Regulation/Anesthesiology Devices Quality System Regulation/Audiological Products/Adulterated Quality System Regulation/Biologics Listing etc. Quality System Regulation/Biologics Listing, etc. Quality System Regulation/Blood Pressure Monitors Quality System Regulation/Cardiac & Vascular Imaging Systems Quality System Regulation/Cardiac Balloon-Catheters/Adulterated Quality System Regulation/Cardiac Catherization Monitoring & Recording Systems Quality System Regulation/Cardiac Catheters/Adulterated Quality System Regulation/Catheterization Manifolds Angiographic Syringes & Pressure Lines Quality System Regulation/Catheterization Manifolds, Angiographic Syringes, & Pressure Lines Quality System Regulation/Catheters Quality System Regulation/CGMP For Blood & Blood Components Quality System Regulation/Circumcision Clamps Quality System Regulation/Class II Medical Devices Quality System Regulation/Clinical Chemistry Analyzers Quality System Regulation/Colonic Irrigation Systems Quality System Regulation/Compressed Medical Gases Quality System Regulation/Compression Garments Quality System Regulation/Condoms Quality System Regulation/Contact Lenses Quality System Regulation/Contact Lenses/Adulterated Quality System Regulation/contract Sterilizer for Medical Devices Quality System Regulation/Contract Sterilizer Medical Devices Quality System Regulation/Contract Sterilizer, Medical Devices Quality System Regulation/contract Sterilizes Bandages Quality System Regulation/Convenience Kits/Adulterated Quality System Regulation/Counter Pulsation Devices Quality System Regulation/CPR Bags & Laryngoscope System Quality System Regulation/Cranial Helmets/Adulterated Quality System Regulation/Crawford Lacrimal Intubation Sets Quality System Regulation/Cutting Burrs & Drill Bits Quality System Regulation/dBest One-Step HIV1/HIV2 Test Kit/Lacks Application for Premarket Approval Quality System Regulation/Dental Alloy Products Quality System Regulation/Dental Compounds Quality System Regulation/Dental Endosseous Implants & Counter Torque Key/Adulterated Quality System Regulation/Dental Implant Devices Quality System Regulation/Derma Freeze Ethyl Chloride USP/Misbranded Quality System Regulation/Device Labeling/Adulterated/Misbranded Quality System Regulation/Device/Lacks Premarket Approval/Reporting Requirements Quality System Regulation/Devices Quality System Regulation/Diagnostic Ophthalmic Devices Quality System Regulation/Diagnostic X-Ray Equipment/Adulterated Quality System Regulation/Diapulse Device Quality System Regulation/Dilatation Catheters Quality System Regulation/Disposable Syringes Quality System Regulation/EasyLyte Na/K/CL/LI Analyzers Quality System Regulation/Electrocardiographic Monitors/Adulterated Quality System Regulation/Electroencephalographs Quality System Regulation/Electrotherapy Products/Adulterated Quality System Regulation/EMDOGAIN (dental bone fillng material) Quality System Regulation/Emergency Ventilators & Circumcision Clamps Quality System Regulation/Endopouch Pro Quality System Regulation/Endoscopes Quality System Regulation/Endoscopes & Bipolar Forceps Quality System Regulation/Examination Gloves Quality System Regulation/Feeding Tubes Scalp Vein Sets Etc. Quality System Regulation/Feeding Tubes, Scalp Vein Sets, Etc. Quality System Regulation/Fluoresoft 0.35%/Adulterated Quality System Regulation/Gels & Lotions Quality System Regulation/Gels Pads & Powders with Iodine/Adulterated Quality System Regulation/Gels, Pads & Powders with Iodine/Adulterated Quality System Regulation/General Purpose Disinfectants Quality System Regulation/Good Manufacturing Practice for Medical Devices/Adulterated Quality System Regulation/Good Manufacturing Practices for Finished Pharmaceuticals/Adulterated Quality System Regulation/Good Manufacuring Practice/Medical Devices/Adulterated Quality System Regulation/Home Health Monitoring Systems Quality System Regulation/Hyper-Oxy Portable Hyperbaric Chambers Quality System Regulation/Hyperbaric Chambers Quality System Regulation/Hypothermia-Hyperthermia Sevices Quality System Regulation/Imaging Tables Quality System Regulation/Implantable Orthopedic Prosthesis Devices Quality System regulation/Implantable Screws Nails Plates etc. Quality System regulation/Implantable Screws, Nails, Plates, etc. Quality System Regulation/In Vitro Diagnostic Devices Quality System Regulation/Infusion Pumps Quality System Regulation/Interferential Nerve & Muscle Stimulator Device Quality System Regulation/Intraocular Fluid Quality System Regulation/Intraocular Lenses Quality System Regulation/Iodine Seeds & RadioPharmaceutical Products Quality System Regulation/Kyphon Inflatable Bone Tamp/Adultered/Misbranded Quality System Regulation/Lacks Approved PreMarket Approval/Adulterated Quality System Regulation/Lacks Approved Premarket Approval/Misbranded/Adulterated Quality System Regulation/Lacks Premarket Approval/Adulterated Quality System Regulation/Lacks Premarket Notification/Adulterated Quality System Regulation/Lacks Premarket Notification/Adulterated/Misbranded Quality System Regulation/Laparoscopic Instruments Quality System Regulation/Laparoscopic Surgical Devices Quality System Regulation/Latex Gloves Quality System Regulation/Lifepak 500 Automated External Defibrillator Quality System Regulation/Medical Adhesive Bandages Quality System Regulation/Medical Adhesive Bandages/Adulterated Quality System Regulation/Medical Device Reporting Quality System Regulation/Medical Device Reporting Regulation/Misbranded/Adulerated Quality System Regulation/Medical Device Reporting/Adulterated Quality System Regulation/Medical Device Reporting/Adulterated/Misbranded Quality System Regulation/Medical Devices Quality System Regulation/Medical Devices Contract Sterilization Quality System Regulation/Medical Devices Processing Quality System Regulation/Medical Devices Reprocessing Quality System Regulation/Medical Devices/Adulterated Quality System Regulation/Medical Examination Gloves Quality System Regulation/Medical Imaging Electronic Equipment Quality System Regulation/Meditherm Quality System Regulation/Microbiological Specimen Collection & Transport Devices Quality System Regulation/Microkeratome Stainless Steel Blades Quality System Regulation/Millenium Portable Reverse Osmosis System Quality System Regulation/Nasal Tubes/Adulterated Quality System Regulation/Needleless Insulin Injectors Quality System Regulation/NeuroControl Freehand System Quality System Regulation/NeuroControl Freehand System/Adulterated Quality System Regulation/Obstetrical Patient Data Management Systems Quality System Regulation/Oxygen Therapy Systems & Accessories Quality System Regulation/Patient Examination Gloves Quality System Regulation/Patient Lifts & Hygiene Chairs Quality System Regulation/Pediatric Cranial Orthosis Quality System Regulation/Phototherapy Units/Adulterated Quality System Regulation/Phototherapy Units/Misbranded/MDR Reporting/Adulterated Quality System Regulation/Pipelle de Cornier & Assisted Pregnancy Devices Quality System Regulation/Portable Oxygen concentrators/Adulterated Quality System Regulation/Powered Wheelchairs & Electric Adjustable Patient Beds Quality System Regulation/Prefilled Syringes Quality System Regulation/Radiographic film Cassette Holder Devices Quality System Regulation/Re-New II Hybrid Laparascopic Instruments Quality System Regulation/Reporting of Corrections, Removals/Misbranded Quality System Regulation/Reprocessing Biopsy Forceps Quality System Regulation/Reprocessing of Medical Devices Quality System Regulation/Reprocessing of Medical Devices (Reusable Sharps Containers) Quality System Regulation/Respirometers and Peak Flow Meters/Adulterated Quality System Regulation/Reusable Sharps Containers Quality System Regulation/Saline Pre-filled Mammary Implants Quality System Regulation/Scootes Power Chairs Quality System Regulation/Scootes, Power Chairs Quality System Regulation/Skin Test Applicators/Adulterated Quality System Regulation/Somnoplasty Devices Quality System Regulation/Spirometers & Peak Flow Meters Quality System Regulation/Steam autoclaves & Dental Handpieces Quality System Regulation/Steril Absorbable & Non-Absorbable Stainless Steel Sutures Quality System Regulation/Sterile Adhesive Bandages Quality System Regulation/Sterile Bone Screws Quality System Regulation/Sterile Dental Implants & Dental Surgical Instruments Quality System Regulation/Sterile Gauze & Bandage Compresses Quality System Regulation/Sterile Implantable Medical Devices Quality System Regulation/Sterile Ophthalmic Orthopedic & Angiography Convenience Kits Quality System Regulation/Sterile, Implantable Medical Devices Quality System Regulation/Sterile, Ophthalmic, Orthopedic & Angiography Convenience Kits Quality System Regulation/Steris System 1 Processor & Quick Connect Kits Quality System Regulation/Surgical & Patient Examingation Lights Quality System Regulation/Surgical Blades Scalpels & Stitch Cutters/Adulterated Quality System Regulation/Surgical Blades, Scalpels, & Stitch Cutters/Adulterated Quality System Regulation/Surgical Laser Powered Instruments Quality System Regulation/Syringe Manufactures Quality System Regulation/Tanning Beds Quality System Regulation/Textile Medical Products Quality System Regulation/The Stripper Micropipette with Tips Quality System Regulation/Thoratec Ventricular Assist Device System Quality System Regulation/Tubes Quality System Regulation/Tubing Sets Plasma Filters and Blood Pumps Quality System Regulation/Tubing Sets, Plasma Filters, and Blood Pumps Quality System Regulation/Ultrasound Systems Quality System Regulation/Urinary Drainage Bags Quality System Regulation/Uropatch/Medical Device Reporting Regulation Quality System Regulation/Videoflouroscopes/Adulterated Quality System Regulation/Water Purification Systems for Hemodialysis Quality System Regulation/Water Purification Systems/Adulterated Quality System Regulation/Whole Blood Test Kits Quality System Regulation/Wound Care Products Quality System Regulations Quality System Regulations (QSR) for finished devices/adulterated Quality System Regulations (QSR)/Sterile Surgical Procedural Kits Quality System Regulations / Medical Devices Quality System Regulations for Medical Device Reporting/Misbranded Quality System Regulations for Medical Devices/Adulterated Quality System Regulations for Medical Devices/Electromyographic Electrodes/Adulterated Quality System Regulations for Medical Devices/Enzymatic Tablets Quality System Regulations/ Medical Device Rpt Regs/Misbranded/Adulterated Quality System Regulations/Adulterated Quality System Regulations/Bone Plates Quality System Regulations/Dental Implant Kits Quality System Regulations/Device Shipment Quality System Regulations/Infusion Pumps & Infusion Tubing Sets Quality System Regulations/Intracranial Electrodes Quality System Regulations/Medical Device Reporting/Adulterated/Misbranded Quality System Regulations/Medical Device Reporting/Electronic Records/Adulterated Quality System Regulations/Reusable Sharps Containers/Adulterated Quality System Regulations/Sharp Containers Quality System Regulations/Sterilants & Disinfectants Quality System Regulatory Adulterated/Misbranded Quality System Regultion/Steam Sterilizers Quality System Requirement Quality System Rgulations/Clinical Steam Sterilizers Quality System/Good Manufacturing Practice for Medical Devices Regulation/Adulterated/Misbranded Quality System/Good Manufacturing Practice for Medical Devices Regulation/Orthopedic Implants Quality System/Good Manufacturing Practice for Medical Devices/Adulterated Quality System/Good Manufacturing Practice for Medical Devices/Synvisc Hylan G-F 20/Adulterated Quality System/Good Manufacturing Practice/Dry-heat Sterilizers Quality System/Good Manufacturing Practice/Medical Devices Quality Systems Regulation/Adulterated Quality Systems Regulation/Infusion Device Analyzers/Adulterated Quality Systems Regulation/Patient Examination Gloves/Adulterated Quality Systems Regulation/Steam Sterilizers/Adulterated Quality Systems Regulations for Medical Devices/Adulterated Quality Sytem Regulation/Thrombectomy Catheter Systems/Adulterated Quinaglute Dura-Tabs/CGMP for Finished Pharmaceuticals/Adulterated R Radiological Health/Records & Report/Performance Standards Rapid Drug Screen/Adulterated/Lacks Premarket Approval/Misbranded Reagents/Lacks "May Proceed Notice" or "Release Notice" Red Snapper Fillets/Import Not Held for FDA Inspection Red Yeast Extract (Lovastain)/Lacks New Drug Application/Misbranded Red Yeast Rice Powder/Lacks New Drug Approval/Misbranded Red Yeast Rice Product/Lacks Approved New Drug Application/Misbranded Refusal to Permit Entry/Inspection Regulatory Problem/Directional Flow Compressible Limb Sleeve Rejuvenique/Lacks Premarket Approval/Misbranded Repacked Prescription Drug Products Reprocessed Single Use Devices/Adulterated/QSR/Device Registration Rife Technology Products/Adulterated/Lacks Premarket Approval/Misbranded Risperdal/Dear Healthcare Provider Letter/False, Misleading Claims S Safety Performance Standard for Cabinet X-ray Systems Saizen/New Drug/Labeling/Misbranded Sale for Slaughter as Food/Adulterated Salmonella Adulteration/Circumvention of Import Alert Salmonella Contamination/Adulterated Sanalyn/Lacks Approved New Drug Application Sare-Point Needle Cover/Adulterated/Misbranded Seafood HAACP/CGMP for Foods/Adulterated Seafood HACCP Seafood HACCP/adulterated Seafood HACCP/Adulterated Seafood HACCP/Adulterated/Misbranded Seafood HACCP/Alligator Products Seafood HACCP/Battered Halibut and Battered Cod Seafood HACCP/Bluefish Seafood HACCP/Catfish Products/Adulterated Seafood HACCP/CGMP for Foods/Adulterated Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions Seafood HACCP/CGMP Manufacturing, Packing or Holding Human Food/Adulterated Seafood HACCP/CGMP Regulations in Manufacturing, Packing, Holding food for Human Consumption Seafood HACCP/CGMP/Misbranded Seafood HACCP/Cooked Crabmeat Seafood HACCP/Cooked Lobster Seafood HACCP/Cooked Sea Cucumber Products Seafood HACCP/Cooked Shrimp & Crab Seafood HACCP/Crab and Crab Sections Seafood HACCP/Crabmeat Seafood HACCP/Crabmeat Processing Facility/Adulterated Seafood HACCP/Crabmeat Products Seafood HACCP/Crabmeat Ravoli Seafood HACCP/Crabmeat/Adulterated Seafood HACCP/Crawfish Products Seafood HACCP/Deviled Crab Processing Facility Seafood HACCP/Dungeness Crab Seafood HACCP/Food Labeling/Adulterated/Misbranded Seafood HACCP/Food Labeling/Misbranded Seafood HACCP/Fresh Crabmeat Seafood HACCP/Fresh Tuna and Mahi Mahi Seafood HACCP/Fresh Tuna and Marlin Seafood HACCP/Fresh Tuna and Marlin/Adulterated Seafood HACCP/Frozen Catfish/Adulterated Seafood HACCP/Frozen Raw and Cooked Shrimp Seafood HACCP/Frozen Raw Shrimp Seafood HACCP/GMP for Foods/Adulterated Seafood HACCP/GMP for Foods/Fresh Tuna & Marlin/Adulterated Seafood HACCP/GMP Mfr, Packing, Holding Food Seafood HACCP/GMP Requirements for Foods Seafood HACCP/GMP Requirements for Foods/Caviar/Adulterated Seafood HACCP/GMP Requirements for Foods/Tuna & Marlin/Adulterated Seafood HACCP/Good Manufacturing Practice Regulations Seafood HACCP/Good Manufacturing Practices Requirement for Foods Seafood HACCP/Histamine Forming Fish/Adulterated Seafood HACCP/Insanitary Conditions Seafood HACCP/Insanitary Conditions/Adulterated Seafood HACCP/Misbranded Seafood HACCP/Oysters Seafood HACCP/Pasterized Crabmeat Seafood HACCP/Perch/Adulterated Seafood HACCP/Ready-to-Eat Crabmeat Seafood HACCP/Ready-to-Eat Crawfish Product/Adulterated Seafood HACCP/Seafood Chowders Seafood HACCP/Shrimp Seafood HACCP/Smoked Herring and Salted Codfish Seafood HACCP/Smoked Salmon Seafood HACCP/Special Requirements for Imported Products Seafood HACCP/Tuna and Cheese Sandwich Products Seafood HACCP/Tuna Fish Sandwiches Seafood HACCP/Tuna Salad Sandwiches Seafood HACCP/Tuna Salad Sandwiches/Adulterated Seafood HACCP/Tuna Sandwich Seafood HACCP/Vacuum Packed Crawfish Tail Meat Seafood HACCP/Vacuum Packed Crawfish Tail Meat/Adulterated Seafood HACCP/Vacuum Packed Fresh Fish Seafood HACCP/Vacuum Packed Smoked Fish/Adulterated Seafood HACCP/Vacuum-Packaged Hot Smoked Seafood Products Seafood HACCP/Vacuum-Packed Cooked Lobster Meat Seafood HACCP/Vacuum-Packed Fried Fish Cakes Seafood HACCP/Vacuum-Packed Smoked Seafood Seafood HACCP/Whole Cooked Crab and Fresh Tuna Seafood Processing Regulations Seafood Processing Regulations/HACCP Seafood Shipment/Fish Maw/Labeling/Misrepresentation Seafood/HACCP/CGMP for Foods/Adulterated Seafood/Lacks "May Proceed Notice" or "Release Notice" Seasilver/New Drug/Labeling/Misbranded Self Pap/Lacks Premarket Notification/Adulterated/Misbranded Sesame Seeds/Not Available for FDA Examination Shipment Documentation Shipment Documentation/Bananas Shipment of Blood in Interstate Commerce by Unlicensed Facility Shipment/Entry Not Held Intact Shipment/Frozen Cooked Shrimp Shipment/Lacks Shipment/Lacks "May Proceed Notice" or "Release Notice" Shipment/Lacks"May Proceed Notice" or "Release Notice" Shrimp/Adulterated Silicone Products Single-Use Device Reprocessing/Adulterated/Misbranded Skin-Cap Spray Slaughter for Human Food/Adulterated Sleep Apnea Goldilocks (SAGA)/Marketing without PreMarket Notification Submission (510K) Smoked Fish/Lacks "May Proceed Notice" or "Release Notice" Smoothbeam/Premarket Notification Procedure/Adulterated Snapper/Lacks "May Proceed Notice" or "Release Notice" SnorBan Mouthpiece/Adulterated/Misbranded Snow Peas/Entry Not Held Intact Snow Peas/Presented for Destruction are not the Original Product Sobriety Aid Somatotropin (Human Growth Hormone) Promoted, Distributed for Unapproved Use Source Plasma Control Violations Source Plasma/Plasmaphoresis/Production & Process Controls Soy Products/Lack Approved New Drug Application Soybean Sprout/Insanitary Conditions/Adulterated Spectacle Frames/Lacks"MayProceed Notice"or"Release Notice" Sponsor Sponsor Obligations Sponsor/Clinical Investigator Sponsor/Monitor Sponsor/Monitor/Contract Research Organization Sports Bar/Misbrnaded/Food Labeling Sprouts/ Insanitary Conditions/Adulterated Sprouts/Adulterated St. Lucia Eye Drops/Lacks Approved New Drug Application/Promotional Claims/Labeling/Misbranded Stability Testing/Ophthalmic Drugs Stagesic -10/Lacks New Drug Approval Application/Misbranded Standard for Human Blood & Blood Products/Adulterated Steak Sauce Shipment Sterile & Non Sterile Medical Dental Needles and Syringes Sterile and Bulk Drug Products Sterile Electrolysis Needles Sterile Eye Wash & Eye Cups/Quality System/Good Manufacturing Practices Sterile Finished Mfr Operation/Adulterated/GMP's for Mfr Processing Holding/Finished Products Sterile Finished Mfr Operation/Adulterated/GMP's for Mfr, Processing, Holding/Finished Products Sterile Gowns and Drapes Sterile Pharmaceutical Chemicals Sterile Pharmaceutical Manufacturing Facility/cGMP Sterile Surgeon Gowns & Gloves Stoneware Mugs/Lacks "May Proceed Notice" or "Release Notice" Street Drug Alternative Street Drugs Alternative Strontium Chloride SR-89/New Drug/Labeling/Misbranded Sub-Potency Vitamin C/Misbranded Subsidiary Firm/cGMP Substituting Labeling and Selling Muenster Cheese as Monterey Jack or Mozzarella Cheese Substituting, Labeling, and Selling Muenster Cheese as Monterey Jack or Mozzarella Cheese Sugardyne Skin Wound Protectant Summit Technology Omnimed Excimer Laser Sunlamp Products Sunscreen Sunscreen Products Suntanning Products Surgical and Dental Hand Instruments Surgical and Dental Instruments Swordfish/Entry Not Held Intact Synthetic Ephedrine Alkaloid/New Drug Synthetic Ephedrine Alkaloids/New Drug Syringe Infusion Pump Syrup Products T Tamarind/Import Not Held for FDA Inspection Tanning Beds Tanning Beds & Booths Tanning Facility/Federal Performance Standard for Sunlamp Products/Misbranded Television Broadcast Advertisement/Flonase Television Broadcasting Advertisement/Lescol Television Product/Electronic Product Radiation Control Television/Computer Monitor Factories/Automatic Detention TENS device & EMS unit/Adulterated/Lacks PMA/Misbranded/Not Substantially Equivalent Test Kits/Lacks Premarket Approval Export Notification Etc. Test Kits/Lacks Premarket Approval, Export Notification, Etc. Testing Laboratory/Analyses Performances/Lack Test Method Validation & General Laboratory Practices Testing Laboratory/Human Tissue Intended for Transplantation Tetanus/LM1 Nux Vomica & Udder Symptom/Lacks Premarket Approval/Misbranding Tetanus/LM1, Nux Vomica, & Udder Symptom/Lacks Premarket Approval/Misbranding Thallium-201(inj.)/Lacks Approved New Drug Application/Misbranded/Adulterated Thalomid/Promotional Activities for Unapproved Uses Therapy Devices Thermal Image Processor Photonic Stimulator/Lacks Premarket Approval/Promotional Claims Thermal Image Processor, Photonic Stimulator/Lacks Premarket Approval/Promotional Claims Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers/Seafood HACCP Tinted Contact Lenses/Adulterated/Misbranded Tinted Contact Lenses/Lack Premarketing Approval/Misbranded Tissue Bank Tissue Bank/Standard of Operation Tobacco Products/Adulterated Tobacco Products/Adulterated/Misbranded Tomato Sauce/Misbranded Topical Liquid Drug Products Trandermal Delivery System/New Drug Transdermal Nitroglycerin Travel Kit Toothpaste Mouthwash etc./Lacks "May Proceed Notice" or "Release Notice" Travel Kit, Toothpaste, Mouthwash, etc./Lacks "May Proceed Notice" or "Release Notice" Triaxon/Lacks New Drug Approval Application/Labeling False & Misleading/Misbranded Trican (tiratricol)/Unapproved New Drug Application/Misbranded/Not a Dietary Supplement Tropical Antifungal Drug Products/Lacks New Drug Approval/Misbranded Tubing Sets Tuna/Entry Not Held Intact/Adulterated Turtles Tylenot Caplets & Perfumery Products/Shipment Not Held Intact U Udon Sauce & Soba Sauce/Food Labeling Ulti-Lance/Lacks "May Proceed Notice" or "Release Notice" Ultra High Temperature Milk Products/GMP Ultrasonic Probes/Promotional Claims Ultrasonic-Dissection/Aspiration Ultrasound Measuring Devices Unapproved Animal Drug Use in Animal Feed/Adulterated Unapproved Drug Use/Hydrea & Droxia Unapproved Food Additive/Adulterated Unapproved Food Additive/Unauthorized Nutrient Content Claim Unapproved Food Additives/LowCarb Bar/Misbranded/Adulterated Unapproved New Animal Drug/Adulterated Unapproved New Animal Drugs/Extralabel Drug Use/Adulterated Unapproved New Drug Unapproved New Drug Human Animal/GMP/Adulterated/Misbranded Unapproved New Drug Promotional Claims/Misbranded Unapproved New Drug, Human, Animal/GMP/Adulterated/Misbranded Unapproved New Drug/Adulterated Unapproved New Drug/Adulterated/Misbranded Unapproved New Drug/GMP for Finished Pharmaceuticals/Misbranded Unapproved New Drug/Lacks New Drug Application Unapproved New Drug/Misbranded Unapproved New Drug/Misbranded/False or Misleading Unapproved New Drugs/Labeling Unapproved Prescription Drugs soliciting Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus; and Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure the H1N1 Virus Unauthorized Health & Nutrition Claims/Hoody's Low Salt Peanuts/Misbranded Unauthorized Health Claims/Juice Products/Misbranded/Labeling Undeclared Color Additives/GMP Mfr, Packing, Holding Human Food/Adulterated/Misbranded Undeclared Drug Claims Unlicensed Autologous Blood Unlicensed Blood Band & Transfusion Service/Adulterated Unpasteurized Orange Juice/Labeling/Misbranded/Salmonella Contamination Unsanitary Conditions/GMP/Bean Sprout Production Facility Uterine Balloon Therapy System/QS/GMP for Medical Devices Regulation/Adulterated V Vanilla/Lacks "May Proceed Notice" or "Release Notice" Variegate Products VasoSeal ES Vascular Hemostasis Device/Promotional Claims/Labeling etc. VasoSeal ES Vascular Hemostasis Device/Promotional Claims/Labeling, etc. Ventilators for Neonatal Use/Quality System/GMP for Medical Devices Regulation/Adulterated Ventricular Assist Device (VAD)/Promotional Claims Verapamine Hydrochloride/Lacks "May Proceed Notice" or "Release Notice" Vessel Watering Point Sanitation Vessel Watering Point/Insanitary Conditions Vessel Watering Point/Interstate Conveyance Sanitation Vessel Watering Points Veterinary Clinic Veterinary Drug Compounding Veterinary Drug Compounding/Adulterated Veterinary Drug Manufacturing Facility for Finished Pharmaceuticals/Adulterated Veterinary Drug Manufacturing Facility/CGMP's for Finished Pharmaceuticals Veterinary Drug Manufacturing Facility/Good Manufacturing Practice/Finished Pharmaceuticals Veterinary Drug Products/Adulterated Veterinary Drug Repacking Facility/good Manufacturing Practices/Finished Pharmaceuticals Veterinary Drugs Veterinary Drugs / Finished Pharmaceuticals Veterinary Drugs/CFR Deviations Veterinary Drugs/Good Manufacturing Practices Veterinary Feed Directive Drugs/Adulterated/Misbranded Veterinary Homeopathic Products Veterinary Medicine Veterinary Prescription Drug/Illegal Purchase Holding & Sale Veterinary Prescription Drug/Illegal Purchase, Holding & Sale Veterinary Syringes/Not Held Intact for Inspection/Import Violation of Conveyance Sanitation Regulations Violations / Conveyance Sanitation Regulatons Violative Promotion Advertising/Lacking Fair Balance/Misleading Vioxx/Promotional Activities & Materials/False & Misleading Vitro Diagnostic Products W Warehouse/Insanitary Conditions/Adulterated Warehouse/Manufacturing Facility/Insanitary Conditions/Adulterated Water Filled Soothers / Teething Rings Water Hydrants Watering Piping Westbrae Natural Rice Beverage/Labeling/Misbranded Wheat Flour/Entry Not Held Intact for Inspection Whole Tuna/Import Not Held for Inspection Written Standard Operating Procedures X X-Ray Bone Densitometer X-ray CAT System/Misbranded X-ray Equipment/Performance Standards for Diagnostic Radiation Emitting Products X-Ray Systems X-Ray Tables and Tube Stands X-ray, CAT System/Misbranded Y Yo-Yo Lasers