Import Alerts for a Country/Area

KOREA (THE REPUBLIC OF)

DWPE = Detain without physical examination
Import Alert Number Import Alert Type Publish Date Import Alert Name
16-119 DWPE 03/06/2024 "Detention Without Physical Examination of Fish and Fishery Products for Importer and Foreign Processor (Manufacturer) Combinations"
16-120 DWPE 03/26/2024 "Detention Without Physical Examination of Fish/Fishery Products from Foreign Processors (Mfrs.) Not in Compliance with Seafood HACCP"
16-39 DWPE 03/11/2024 "Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes"
16-50 DWPE 06/16/2023 "DETENTION WITHOUT PHYSICAL EXAMINATION OF MOLLUSCAN BIVALVE SHELLFISH"
16-74 DWPE 03/26/2024 "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 Filed Under 21 CFR 108/113 or 114)"
16-81 DWPE 04/29/2024 "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella"
25-21 DWPE 11/08/2023 Detention Without Physical Examination of Enoki Mushrooms from the Republic of Korea and China due to Listeria Monocytogenes
45-02 DWPE 05/02/2024 "Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors."
45-06 DWPE 10/02/2023 "Detention without Physical Examination of Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts"
52-08 DWPE with Surveillance 04/24/2024 "Detention Without Physical Examination of Ceramicware Due to Excessive Lead and/or Cadmium"
53-06 DWPE 05/01/2024 "Detention Without Physical Examination Of Cosmetics That are Adulterated and/or Misbranded Due to Color Additive Violations"
53-17 DWPE 04/23/2024 "Detention Without Physical Examination of Cosmetics Due To Microbiological Contamination"
54-07 DWPE 11/08/2023 "Detention Without Physical Examination of Germanium Supplements for Human Consumption"
54-14 DWPE 04/18/2024 DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT PRODUCTS FROM FIRMS THAT HAVE NOT MET DIETARY SUPPLEMENT GMP
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"
66-40 DWPE 05/02/2024 "Detention Without Physical Examination of Drugs From Firms Which Have Not Met Drug GMPs"
66-41 DWPE 05/02/2024 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"
66-78 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"
68-19 DWPE 03/26/2024 "DETENTION WITHOUT PHYSICAL EXAMINATION OF UNAPPROVED FINISHED NEW ANIMAL DRUGS"
79-01 DWPE with Surveillance 04/02/2021 "Detention Without Physical Examination Plastic Bandages And Cotton Pads Due To Microbiological Contamination"
80-04 DWPE with Surveillance 04/22/2024 "Surveillance and Detention Without Physical Examination of Surgeon's and Patient Examination Gloves"
80-06 DWPE 10/16/2023 "Detention Without Physical Examination of Medical Devices with False or Misleading Labeling"
85-02 DWPE 03/21/2023 "Detention Without Physical Examination of Condoms"
86-11 DWPE 10/16/2023 "Detention Without Physical Exam of Contact Lenses Due to Microbiological Contamination"
89-01 DWPE 03/25/2024 "Detention Without Physical Examination of Misbranded and/or Adulterated Powered Muscle Stimulators and Iontophoresis Devices"
89-04 DWPE 04/10/2024 "Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements"
89-08 DWPE 04/01/2024 "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"
89-16 DWPE 12/11/2023 Detention Without Physical Examination of Products from Medical Device Firms Refusing FDA Foreign Establishment Inspection
98-06 DWPE 04/01/2024 "Detention Without Physical Examination of New Tobacco Products Without Required Marketing Authorization"
99-05 DWPE 05/02/2024 "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides"
99-08 DWPE 05/03/2024 "Detention without Physical Examination of Processed Human and Animal Foods for Pesticides"
99-19 DWPE 05/01/2024 "Detention Without Physical Examination of Food Products Due to the Presence of Salmonella"
99-21 DWPE 03/22/2024 Detention Without Physical Examination of Food Products Containing Undeclared Added Sulfiting Agents
99-22 DWPE 05/02/2024 Detention Without Physical Examination Of Foods Containing Undeclared Major Food Allergens Or Foods That Fail To Properly Label Major Food Allergens
99-23 DWPE 04/17/2024 Detention Without Physical Examination of Produce Due to Contamination With Human Pathogens
99-31 DWPE 12/09/2020 "Detention Without Physical Examination of Food Products Due to the Presence of Melamine and/or Melamine Analogs"
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
99-35 DWPE 03/12/2024 DETENTION WITHOUT PHYSICAL EXAMINATION OF FRESH PRODUCE THAT APPEARS TO HAVE BEEN PREPARED, PACKED OR HELD UNDER INSANITARY CONDITIONS
99-36 DWPE 09/30/2022 "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS FROM COMMERCIAL PROCESSORS FOR FAILURE TO PROVIDE PROCESS INFORMATION"
99-37 DWPE 04/01/2024 "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS AND ACIDIFIED FOODS WITHOUT FILED SCHEDULED PROCESSES"
99-38 DWPE 02/22/2024 "DETENTION WITHOUT PHYSICAL EXAMINATION OF LOW-ACID CANNED FOODS OR ACIDIFIED FOODS DUE TO INADEQUATE PROCESS CONTROL"
99-39 DWPE 04/25/2024 Detention Without Physical Examination of Imported Food Products That Appear to Be Misbranded
99-42 DWPE 05/03/2024 DETENTION WITHOUT PHYSICAL EXAMINATION OF FOODS DUE TO HEAVY METAL (TOXIC ELEMENT) CONTAMINATION
99-49 DWPE 03/26/2024 Detention Without Physical Examination of Devices Without a Unique Device Identifier and/or Matching GUDID Record