Import Alert for Industry Antibiotics (Human/Animal)

Antibiotics (Human/Animal)

DWPE = Detain without physical examination
Import Alert Number Import Alert Type Publish Date Import Alert Name
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
56-02 DWPE 03/18/2011 Detention Without Physical Examination Of Enrofloxacin (Baytril) Labeled For Use In Poultry
66-05 DWPE 12/14/2012 "Foreign Labeled Finished Dosage Parenterals"
66-14 DWPE with Surveillance 09/17/2014 "Reimportation of All Prescription Drugs for Human Use"
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"
66-71 DWPE 08/09/2017 "Detention Without Physical Examination of Human Growth Hormone (HGH), Also Known As Somatropin"
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"
68-01 DWPE 07/27/2011 "Detention Without Physical Examination Of Chloramphenicol"
68-02 DWPE 06/02/2017 "Detention Without Physical Examination Of Veterinary Drugs From Firms That Have Not Met Drug GMPs"
68-09 DWPE with Surveillance 04/01/2017 "New Bulk Animal Drug Substances"
68-19 DWPE 08/01/2017 "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED NEW ANIMAL DRUGS"
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 11/24/2017 Detention Without Physical Examination of Imported Food Products That Appear To Be Misbranded