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
54-16 DWPE 03/12/2024 "DETENTION WITHOUT PHYSICAL EXAMINATION OF PRODUCTS THAT ARE MARKETED AS FOODS, INCLUDING PRODUCTS MARKETED AS DIETARY SUPPLEMENTS, THAT CONTAIN AN ACTIVE PHARMACEUTICAL INGREDIENT"
55-05 DWPE 01/18/2024 "Detention Without Physical Examination Of Finished Dosage Form Drug Products, Active Pharmaceutical Ingredients, and Inactive Ingredients for Potentially Hazardous Microbiological Contamination"
62-05 DWPE 11/02/2021 "Detention Without Physical Examination of Sterile Dosage Form Drugs From Manufacturers Not in Compliance with CGMPs"
66-40 DWPE 05/02/2024 "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
66-41 DWPE 05/06/2024 Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.
66-57 DWPE 11/06/2023 "Detention Without Physical Examination of Foreign Manufactured Unapproved Prescription Drugs Distributed to Individuals in the U.S."
66-66 DWPE 12/26/2023 "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 08/11/2023 "Detention Without Physical Examination of Unapproved Human Growth Hormone (HGH)"
66-76 DWPE 05/26/2022 "Detention Without Physical Examination of Drugs or Active Pharmaceutical Ingredients From Facilities That Have Not Submitted Self-Identifying Information or Paid Facility or Program Fees Required Under GDUFA "
66-78 DWPE 09/11/2023 "Detention Without Physical Examination of Drugs, Based Upon Analytic Test Results"
66-79 DWPE 04/12/2024 "Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection"
68-09 DWPE 02/15/2024 "Detention Without Physical Examination of New Bulk Animal Drug Substances"
68-19 DWPE 03/26/2024 "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"
99-34 DWPE 02/02/2024 DETENTION WITHOUT PHYSICAL EXAMINATION OF DRUGS OR MEDICAL DEVICES FROM FIRMS WITHOUT A VALID DRUG OR MEDICAL DEVICE REGISTRATION AND/OR LISTING
99-39 DWPE 05/08/2024 Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded