Import Alert for Industry Pharm Necess & Ctnr For Drug/Bio

Pharm Necess & Ctnr For Drug/Bio

DWPE = Detain without physical examination
Import Alert Number Import Alert Type Publish Date Import Alert Name
53-06 DWPE 11/03/2017 "Detention Without Physical Examination Of Cosmetics Containing Illegal Colors"
54-16 DWPE 09/26/2017 "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"
55-02 DWPE with Surveillance 11/21/2013 "Increased Surveillance Of Bulk Ingredients Susceptible To Contamination With Diethylene Glycol"
55-03 DWPE 09/09/2014 DETENTION WITHOUT PHYSICAL EXAMINATION OF DIFFERENT FORMS OF HEPARIN AND HEPARIN-RELATED PRODUCTS
55-05 DWPE 08/23/2017 DETENTION WITHOUT PHYSICAL EXAMINATION OF FINISHED DOSAGE DRUG PRODUCTS, ACTIVE PHARMACEUTICAL INGREDIENTS AND INACTIVE INGREDIENTS FOR POTENTIALLY HAZARDOUS MICROBIOLOGICAL CONTAMINATION
61-01 DWPE 07/26/2013 "Gerovital (KH3 - GH3, Etc.)"
61-05 DWPE 03/18/2011 "Methapyrilene and Drug Products Containing Methapyrilene"
61-06 DWPE 12/14/2012 "Detention Without Physical Examination of Skin Cap Spray, Shampoo And Cream"
66-05 DWPE 12/14/2012 "Foreign Labeled Finished Dosage Parenterals"
66-10 DWPE 03/18/2011 Chinese Herbal Medicines
66-35 DWPE with Surveillance 03/27/2015 "Detention Without Physical Examination of Redotex and Other Diet Pills From Mexico"
66-40 DWPE 11/21/2017 "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
66-41 DWPE 11/21/2017 Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
66-57 DWPE 06/08/2017 "Detention Without Physical Examination Of Foreign manufactured Unapproved Prescription Drugs Promoted to Individuals in the U.S."
66-66 DWPE 08/22/2017 "APIs That Appear To Be Misbranded Under 502(f)(1) Because They Do Not Meet The Requirements For The Labeling Exemptions In 21 CFR 201.122"
66-75 DWPE 07/08/2016 DETENTION WITHOUT PHYSICAL EXAMINATION OF IMMUNO-AUGMENTATIVE THERAPY (IAT)
66-76 DWPE 01/05/2017 "Detention Without Physical Examination of Drugs or Active Pharmaceutical Ingredients from Facilities that have not submitted self-identifying information or paid facility fees required under GDUFA"
68-02 DWPE 06/02/2017 "Detention Without Physical Examination Of Veterinary Drugs From Firms That Have Not Met Drug GMPs"
89-08 DWPE 11/15/2017 ***"Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"***
99-32 DWPE 11/22/2017 "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS FROM FIRMS REFUSING FDA FOREIGN ESTABLISHMENT INSPECTION"
99-34 DWPE 07/29/2016 DETENTION WITHOUT PHYSICAL EXAMINATION OF DRUGS OR MEDICAL DEVICES FROM FIRMS WITHOUT A VALID DRUG OR MEDICAL DEVICE REGISTRATION
99-39 DWPE 11/14/2017 Detention Without Physical Examination of Imported Food Products That Appear To Be Misbranded