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FDA's Electronic Reading Room - Warning Letters



Warning Letters Search Results


Search Criteria: Letter Issued Date is greater than or equal to 11/01/1996 and Letter Issued Date is less than or equal to 10/31/1997



   
ADM Division Headquarters  11/13/1996  Minneapolis District Office  Deviation from Good Manufacturing Practice   No   
ASCO Eastern Medical Supply  12/16/1996  Baltimore District Office  Medical Oxygen  No   
Advanced Composite Technologies Inc.  12/13/1996  Dallas District Office  Labeling  No   
Albany Edison Oxygen Co. Inc.  11/21/1996  Buffalo District Office  Medical Oxygen  No   
Aliotte Bakery Cafe Inc.  12/09/1996  New York District Office  Insanitary Conditions  No   
Amazonic Herbals Inc.  12/13/1996  Florida District Office  Herbal Products  No   
Ambix Laboratories Inc.  12/30/1996  New Jersey District Office  Drug Products/Pediculicides  No   
Ambu Incorporation  11/13/1996  Baltimore District Office  Devices/Resuscitators  No   
AmeriTek Inc.  12/02/1996  Seattle District Office  Devices/Test Strips  No   
Amerisource Corporation  11/06/1996  Cincinnati District Office  Drug Products  No   
Anthony Home Health Care Inc.  11/21/1996  New York District Office  Medical Oxygen  No   
Applied Medical Technology Inc.  11/12/1996  Cincinnati District Office  Devices/Gastrostomy Kits  No   
Arcadia Pharmacy Inc.  11/07/1996  Buffalo District Office  Medical Oxygen  No   
Archer Daniels Midland (ADM)  11/26/1996  Kansas City District Office  Medicated Articles  No   
Ashley Valley Medical Center  12/23/1996  Dallas District Office  Mammography Standards  No   
B&D Medical  12/11/1996  Denver District Office  Medical Oxygen  No   
Baptist Health Center - Centerpoint  12/06/1996  Nashville District Office  Mammography Standards  No   
Barker's Dairy  12/19/1996  Seattle District Office  Food/Cattle  No   
Becker Frederick K.  12/06/1996  New York District Office  Food/Caviar  No   
Berlex Laboratories Inc.  12/03/1996  New Jersey District Office  Drug Products  No   
Biosil Limited  12/24/1996  Center for Devices and Radiological Health  Devices/Breast Implants  No   
Boschma Dairy  11/27/1996  Seattle District Office  Food/Cattle  No   
Bottasso Dairy  12/27/1996  San Francisco District Office  Food/Cattle  No   
Brabant Farm  11/01/1996  Buffalo District Office  Food/Cattle  No   
Bunge Corporation  11/06/1996  New Orleans District Office  Vessel Watering Points  No   
C & G Marketing and Manufacturing  11/05/1996  Denver District Office  Sobriety Aid  No   
Carolina Georgia Blood Center  11/15/1996  Atlanta District Office  Blood Products  No   
Central Grocers Co-op Inc.  11/14/1996  Chicago District Office  Insanitary Conditions  No   
Chancey-Folsom Inc.  12/02/1996  Atlanta District Office  Medical Oxygen  No   
Chancy Oxygen Service Inc.  12/23/1996  Atlanta District Office  Medical Oxygen  No   
Cheminova America Corporation  12/11/1996  Florida District Office  Drug Products/Deodorant Spray  No   
Chez Bon Incorporated  12/02/1996  Philadelphia District Office  Nutrition Labeling  No   
Ciba-Geigy Corporation  11/15/1996  New Jersey District Office  Transdermal Nitroglycerin  No   
Cirrus Air Technologies LLC  12/09/1996  New York District Office  Devices/Earplanes  No   
Clean Pack and Quality Dental Products  11/14/1996  Los Angeles District Office  Devices/Endosseous Implants  No   
Colloidal Products Inc.  12/19/1996  Florida District Office  Labeling / New Drug Application   No   
Contract Manufacturing Inc.  12/19/1996  New Orleans District Office  Deviation from Good Manufacturing Practice   No   
Coulee Region Organic Produce Pool  12/12/1996  Minneapolis District Office  Labeling/Cheese  No   
Cox Hugh  11/08/1996  Atlanta District Office  Food/Cattle  No   
Crystal Care International Incorporated  12/30/1996  Center for Devices and Radiological Health  Devices/Hearing Aid  No   
D.O. Weaver and Company  11/18/1996  Denver District Office  Devices/Paste Products  No   
DCI Biologicals Inc.  12/20/1996  Denver District Office  Source Plasma Control Violations   No   
DMD Corporation  12/19/1996  Detroit District Office  Drug Products/Labeling  No   
Dentomed Incorporated  11/18/1996  Baltimore District Office  Devices/Dental Instruments  No   
Dentronix Inc.  11/12/1996  Philadelphia District Office  Devices/Orthopedic Instruments   No   
Diagnostic Solutions Inc.  12/03/1996  Los Angeles District Office  Devices/Test Strips  No   
Digisonics Inc.  11/14/1996  Dallas District Office  Adultered Devices  No   
Diniz Tony F.  11/04/1996  San Francisco District Office  Food/Cattle  No   
Dixon Samuel Jr.  12/10/1996  Philadelphia District Office  Food/Cattle  No   
Doansco Welding Supplies Inc.  12/03/1996  Cincinnati District Office  Medical Oxygen  No   
Dolphin Best Friends  11/05/1996  Florida District Office  Octopus Shipment  No   
Dyna Dental Engineering B.V.  12/06/1996  Center for Devices and Radiological Health  Devices/Dental Instruments  No   
Dynamic Systems Inc.  11/13/1996  Atlanta District Office  Deviation from Good Manufacturing Practice   No   
E-Z-EM Inc.  12/03/1996  New York District Office  Drug Products  No   
EM Industries Inc.  12/26/1996  New Jersey District Office  In Vitro Diagnostic Products  No   
Eon Labs Manufacturing Inc.  11/04/1996  New York District Office  Drug Products  No   
Foster Farms of California  11/06/1996  Seattle District Office  Food  No   
Gemini Pharmaceuticals Inc.  11/14/1996  New York District Office  Drug Component Ingredients  No   
Giant Repacking Center  11/27/1996  Baltimore District Office  Drug Products  No   
Gouveia Daniel D.  12/09/1996  San Francisco District Office  Food/Cattle  No   
Grandma Morrison's  11/01/1996  Detroit District Office  Acidity Levels  No   
Greenbrier Respiratory Care Services Inc.  11/22/1996  Baltimore District Office  Medical Oxygen  No   
Greenwood County Hospital  12/09/1996  Dallas District Office  Mammography Standards  No   
Hammer Inc.  11/25/1996  Kansas City District Office  Medical Oxygen  No   
Hilton Head Medical Center and Clinics  12/23/1996  Center for Biologics Evaluation and Research  IRB (Institutional Review Board)   No   
Home Healthcare Technologies Inc.  12/06/1996  Minneapolis District Office  Medical Oxygen  No   
Imaginative Optics  11/27/1996  Center for Devices and Radiological Health  Devices/Laser Systems  No   
J & K Cattle Company  11/19/1996  Dallas District Office  Medicated Feeds  No   
J-F Medical Systems Intl. Inc.  11/26/1996  Dallas District Office  Devices/Computer Systems  No   
J.G. Van Holten & Sons Inc.  11/12/1996  Minneapolis District Office  Insanitary Conditions  No   
Kaplan & Zubrin  12/26/1996  New Jersey District Office  Food/Pickles  No   
Koetsier Dairy  11/15/1996  San Francisco District Office  Food/Cattle  No   
L'Aprina Inc.  12/23/1996  Baltimore District Office  Drug Products/Topical Aspirin  No   
LSG Lufthansa - Sky Chefs  12/16/1996  San Francisco District Office  Airline Meals  No   
LSG Sky Chef Inc.  12/11/1996  Dallas District Office  Catering Facilities  No   
Landolt Dairy  12/12/1996  Seattle District Office  Food/Cattle  No   
Laser Labs  12/02/1996  Florida District Office  Devices/Laser Systems  No   
Leone Russell F.  11/01/1996  Buffalo District Office  Food/Cattle  No   
Lindsay Farms  11/12/1996  Kansas City District Office  Medicated Feeds  No   
Lunar Corporation  12/20/1996  Center for Devices and Radiological Health  X-Ray Bone Densitometer  No   
Lutheran Medical Center  12/05/1996  Cincinnati District Office  Mammography Standards  No   
Luv'n Care LTD.  12/20/1996  New Orleans District Office  Water Filled Soothers / Teething Rings   No   
M. D. Anderson Cancer Center  11/07/1996  Center for Biologics Evaluation and Research  Sponsor/Monitor/Contract Research Organization   No   
MEDICAL Z S.A.  11/08/1996  Center for Devices and Radiological Health  Medical Devices  No   
Marcelino Amaral and Sons Dairy  12/13/1996  San Francisco District Office  Food/Cattle  No   
Marks Brothers Pickle Company Inc.  11/21/1996  Minneapolis District Office  Acidity Levels  No   
Marlen Manufacturing and Development Co.  12/26/1996  Cincinnati District Office  Devices/Colostomy Rods & Ileostomy/Colostemy/Urostomy Bags   No   
Marshalltown Medical & Surgical Center  12/20/1996  Kansas City District Office  Quality Control Violations  No   
Mathys Medical Ltd.  11/05/1996  Center for Devices and Radiological Health  Devices  No   
McNeil Consumer Products Co.  12/11/1996  Center for Drug Evaluation and Research  Approved Labeling  No   
Medical Arts Clinic  12/09/1996  Dallas District Office  Mammography Standards  No   
Medical Services of America Inc.  11/05/1996  Baltimore District Office  Medical Oxygen  No   
Mellinger Arthur  12/16/1996  Philadelphia District Office  Food/Cattle  No   
Michele's Original  12/12/1996  Philadelphia District Office  Labeling  No   
Micro Mega S.A.  12/20/1996  Center for Devices and Radiological Health  Sterile Electrolysis Needles  No   
Micro-Precision Instruments Ltd.  12/19/1996  Center for Devices and Radiological Health  Medical Devices  No   
Microbiologics Inc.  12/13/1996  Minneapolis District Office  In Vitro Diagnostic Products  No   
Mid-South PCM Group P.C.  12/19/1996  Center for Devices and Radiological Health  Contact Lenses  No   
Middle Georgia Medical Supply  11/14/1996  Atlanta District Office  Medical Oxygen  No   
Mission Pharmacal Co. Inc.  12/20/1996  Dallas District Office  Deviation from Good Manufacturing Practice   No   
Modern Products  12/31/1996  Minneapolis District Office  Laxative Products  No   
Montgomery Medical Equipment  12/02/1996  Atlanta District Office  Medical Oxygen  No   
Multi-Clean Incorporated  12/30/1996  Minneapolis District Office  Drug Products/Antimicrobial Soap   No   
Nace James S.  11/04/1996  San Francisco District Office  Food/Cattle  No   
National Biochemicals Corp.  12/24/1996  Cincinnati District Office  Bulk Drug Substances  No   
National Gypsum Company  11/04/1996  New Orleans District Office  Vessel Watering Points  No   
National Welding Supply Inc.  11/19/1996  New Orleans District Office  Medical Oxygen  No   
Nestle USA  12/11/1996  Minneapolis District Office  Food/Infant Formula  No   
NutraMax Products Inc.  11/07/1996  New Jersey District Office  Drug Products/Ophthalmic Solutions   No   
Olan Laboratories Inc.  12/26/1996  New York District Office  Drug Products/Antifungal Solution & Wash   No   
Organico Institute Corporation  11/18/1996  Minneapolis District Office  Food Products  No   
Osprey Seafood Co. Inc.  11/29/1996  Atlanta District Office  Food/Crabmeat  No   
Our Lady of the Lake Regional Medical Center Blood Bank  12/05/1996  New Orleans District Office  Computer Systems  No   
Padgett William B.  12/20/1996  Atlanta District Office  Food/Cattle  No   
Performance Nutrition Inc.  12/04/1996  Dallas District Office  Drug Products  No   
Perma Pure Inc.  12/12/1996  New Jersey District Office  Devices/Medical Gas Analyzers  No   
Pete Soule & Sons  11/20/1996  Buffalo District Office  Food/Cattle  No   
Plaza-Wilson DME Inc.  11/25/1996  Atlanta District Office  Medical Oxygen  No   
Prather Welding Supply Inc.  12/17/1996  Atlanta District Office  Medical Oxygen  No   
Premier Laser Systems Inc.  11/06/1996  Center for Devices and Radiological Health  Devices/Laser Systems  No   
Presidents Specialty Healthcare  11/15/1996  Minneapolis District Office  Medical Oxygen  No   
Procare Home Health Care Services Inc.  12/12/1996  Atlanta District Office  Medical Oxygen  No   
Propharma Inc.  12/04/1996  Florida District Office  New Drugs  No   
Purdue Frederick Company  11/20/1996  Division of Drug Marketing, Advertising, and Communications  Drug Products/Imorphint Sulfate Tablets   No   
R.J.S. Scientific Inc.  11/04/1996  New York District Office  Deionized Water System  No   
Reds Seafood Inc.  11/04/1996  New Orleans District Office  Food/Crabmeat  No   
Regional Medical Rental & Sales  12/23/1996  New Orleans District Office  Medical Oxygen  No   
Roberts Oxygen  12/04/1996  Baltimore District Office  Medical Oxygen  No   
Roseland Elevator  11/05/1996  Minneapolis District Office  Medicated Feeds  No   
Rotech Medical Corp.  11/07/1996  New Orleans District Office  Deviation from Good Manufacturing Practice   No   
ST Services  11/04/1996  New Orleans District Office  Vessel Watering Points  No   
Saturn-Chem  12/20/1996  Kansas City District Office  Labeling / New Drug Application   No   
Sbrocco International Inc.  11/22/1996  Florida District Office  Shipment Documentation  No   
Shanghai Da Hu Medical Equipment Factory  12/06/1996  Center for Devices and Radiological Health  Devices/Utrasonic Therapy  No   
Silva Brothers Dairy  12/09/1996  San Francisco District Office  Food/Cattle  No   
Southwest Airlines  11/07/1996  San Francisco District Office  Insanitary Conditions  No   
Stedim S.A.  11/27/1996  Center for Devices and Radiological Health  Packaging Materials  No   
Suncoast Medical Group Inc.  11/07/1996  Center for Devices and Radiological Health  Sponsor/Monitor/Contract Research Organization   No   
TEM Enterprises  12/05/1996  San Francisco District Office  Airline Meals  No   
TGM Products Inc.  11/18/1996  New York District Office  Devices/Surgical Instruments  No   
Tasty Seafood Company Inc.  11/22/1996  Florida District Office  Fresh Dolphin / Mahi-Mahi  No   
Technical Products Inc. of Georgia USA  11/21/1996  Atlanta District Office  Silicone Products  No   
Tianna Farms Kitchen  11/25/1996  Minneapolis District Office  Product Deficiencies  No   
Tropic Fish & Vegetable Center  12/05/1996  San Francisco District Office  Insanitary Conditions  No   
U.S. Welding Inc.  11/27/1996  Denver District Office  Medical Oxygen  No   
University Plasma Inc.  12/11/1996  New Orleans District Office  Blood Products/Physicians Certification   No   
Vriesendorp Huibert M.D.  11/19/1996  Center for Biologics Evaluation and Research  Clinical Investigator  No   
Walker Welders Supply Co. Inc.  12/30/1996  New Orleans District Office  Medical Oxygen  No   
Women's Health Imaging  11/14/1996  Seattle District Office  Mammography Standards  No   
Wyandot Memorial Hospital  12/03/1996  Cincinnati District Office  Mammography Standards  No   
X-Ray Associates Inc.  12/03/1996  Cincinnati District Office  Mammography Standards  No   
York River Seafood Co. Inc.  11/15/1996  Baltimore District Office  Crabmeat Processing  No   

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