FDA import alert
Import Alert 68-09
Detention Without Physical Examination of New Bulk Animal Drug Substances
7
Red-list entries
0
Green-list entries
2
Countries
2024-02-15
Last change seen
What being on this list means
Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →
A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.
Red-list entries by country
Firms on this red list
Showing 7 of 7 entries — search a specific firm on the free checker.
Aviva Pharmaceuticals Ltd
05/03/2016
China · Vitamin, Mineral, Proteins and Unconventional Dietary Specialities For Humans and Animals, N.E.C.
HANGZHOU JHECHEM CO LTD
04/29/2021
China · Enrofloxacin (Fluoroquinolone)
Neostar United Industrial Co., Ltd.
07/09/2021
China · Antifungal N.E.C.
Shaanxi Kingsci Biotechnology Co Ltd
09/19/2022
China · Exhibits - Other Drug Related Items N.E.C.; Additives, N.E.C.
The United Laboratories (Inner Mongolia) Co. Ltd.
09/23/2015
China · Amoxicillin Trihydrate (Penicillin, Synthetically Produced)
ZHENGZHOU SIGMA CHEMICAL CO
03/31/2017
China · Anthelmintic, N.E.C.; Praziquantel (Anti-Schistosomal)
Reform Italia Srl
02/15/2024
Italy · Anti-Infective, Topical N.E.C.
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