FDA red lists by country
Korea (The Republic Of): firms on FDA import alerts
Firms from Korea (The Republic Of) currently listed on FDA import alert red lists — meaning their products can be detained at the US border without physical examination (DWPE) — based on the official FDA import alert pages.
753
Red-list entries
49
Import alerts involved
7
Green-list entries
Top import alerts listing Korea (The Republic Of) firms
- IA 89-08Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)107 entries
- IA 66-41Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.94 entries
- IA 45-02Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.71 entries
- IA 99-08Detention without Physical Examination of Processed Human and Animal Foods for Pesticides57 entries
- IA 16-74Detention Without Physical Examination of Uneviscerated Fish or Partially Eviscerated Fish that are either Salt-Cured, Dried, Smoked, Pickled, Fermented or Brined (i.e., excluding LACF and Acidified Products Filed Under 21 CFR 108/113 or 114)44 entries
- IA 66-40Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs37 entries
- IA 16-39Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes34 entries
- IA 66-79Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection32 entries
- IA 16-81Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella31 entries
- IA 99-39Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded28 entries
- IA 53-06Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations23 entries
- IA 16-120Detention Without Physical Examination of ***Fish and Fishery*** Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP ***Regulation***21 entries
Red-listed firms from Korea (The Republic Of)
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