FDA import alert
Import Alert 55-05
Detention Without Physical Examination Of Finished Dosage Form Drug Products, Active Pharmaceutical Ingredients, and Inactive Ingredients for Potentially Hazardous Microbiological Contamination
7
Red-list entries
0
Green-list entries
6
Countries
2025-10-03
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
| Country | Entries |
|---|---|
| Mexico | 2 |
| Canada | 1 |
| China | 1 |
| India | 1 |
| Korea (The Republic Of) | 1 |
| United States | 1 |
Firms on this red list
Showing 7 of 7 entries — search a specific firm on the free checker.
Delta Pharma Inc.
05/22/2013
Canada · Miscellaneous Patent Medicines, Etc.
GFA Production Xiamen Co., Ltd.
02/16/2023
China · Benzalkonium Chloride (Pharmaceutic Necessity - Preservative); Antibiotic N.E.C.; Adsorbant N.E.C.
Contacare Ophthalmics & Diagnostics
08/23/2017
India · Hydroxypropyl Methylcellulose (Pharmaceutic Necessity - Suspending Agent), Pharma Necess; Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent), Pharma Necess; Iopydol (Diagnostic Aid) (Drugs), Human - Rx/Single Ingredient, Small Volume Parenteral <100ml
Neo Vision Co., Ltd.
12/13/2016
Korea (The Republic Of) · Pharm Necess & Ctnr For Drug/Bio; Antibiotics (Human/Animal); Human and Animal Therapeutic Biologic and Biosimilar Drugs
Beiersdorf Manufacturing Mexico SA de CV
10/03/2025
Mexico · Ultraviolet Screen/Sunscreen N.E.C.
Brady Mexico S De RL de CV
08/26/2016
Mexico · Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent); Ethyl Oleate (Pharmaceutic Necessity - Vehicle); Water, Purified (Eyewash)
Sperian Eye & Face Protection Inc
08/26/2016
United States · Sodium Chloride (Pharmaceutic Necessity - Tonicity Agent); Ethyl Oleate (Pharmaceutic Necessity - Vehicle); Water, Purified (Eyewash)
Does this alert touch your supply chain?
Put your suppliers on watch: we re-check this list (and every other import alert) daily against the official FDA source and email you the day a firm you depend on is added or removed.
Monitor my suppliers