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.

756

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)105 entries
  • IA 66-41Detention Without Physical Examination of Unapproved New Drugs Promoted In The U.S.95 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 Pesticides59 entries
  • IA 16-74***"Detention 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 Produced in Accordance with 21 CFR part 113 or 114)"***44 entries
  • IA 66-40Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs36 entries
  • IA 16-39Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes34 entries
  • IA 16-81Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella32 entries
  • IA 66-79Detention Without Physical Examination of Drugs From Foreign Establishments Refusing FDA Inspection32 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***22 entries

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Red-listed firms from Korea (The Republic Of)

Showing 50 of 638 firms. Open a firm for its full FDA record, or search a specific one on the free checker.

FirmAlerts
A. Won Commercial Co.16-39
ABATON IND89-08
ABIO Materials Co., Ltd66-41
Absology Co., Ltd.89-08
Acmedi Korea Co.89-08
Across Co., Ltd89-08
Adwin Korea Corp.66-41
AERIM JUNG99-34
Agricultural Corporation Cheongdo WonGam CO.,Ltd.99-08, 99-21
Agricultural Corporation Juwon Farm99-23
AINCOS LTD66-79
Aju Medical Co., Ltd.89-04
ALALRI CO., LTD.99-08
ALL FOOD TRADING16-81
ALPHANOX CO., LTD.66-41
Amaros Co., Ltd66-40
Ami Cosmetics Co., Ltd.53-06
AMORE PACIFIC53-06
AMORE PACIFIC CORPORATION53-06
Amorepacific Corporation - Daily Beauty Plant66-41
AnD Food16-81
Apexel Co., Ltd.66-79
Aquavit Life Sciences, Inc.89-08
Aram Cosmetic Co., Ltd66-79
AriBio H&B66-78
Ariul Company99-32
Aromatica Company66-41
ASAN PHARM CO LTD89-08
Bada Fishery Co.16-39
Bada Myeongga99-42
BADAONE CO., LTD.16-81
Banchandanji Co. Ltd.16-120
Barox Co., Ltd.66-40
BBB INC89-08
BEOMCHON FERMENTED FOODS99-32
Bing Grae Company Ltd. (Office & Plant)45-02
BIO PORT KOREA,INC.66-41, 99-39
Biomaterials Korea Inc.89-08
Bionote, Inc.89-08
Bioport Korea, Inc.66-41, 99-39
BL Cosmetic Co., Ltd.66-79
Blink Lash Stylist & Care C/O Ag Co Ltd53-06
Blue Sea Village99-08
Blueberry NFT Co., Ltd85-02
Bluesea Food16-74
BM FOOD99-08
BNB MEDICAL CO., LTD.89-08
BNC Global99-34
BO SUNG FOODS CO., LTD.16-74
Boditech Med, Inc.89-08

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