FDA Warning Letter to East CK Trading Inc.
Summary
The FDA issued a warning letter to East CK Trading Inc. for significant violations of the Foreign Supplier Verification Program (FSVP) regulation. The company failed to develop and maintain an FSVP for imported foods, leading to potential refusal of admission and detention without physical examination.
What changed
The U.S. Food and Drug Administration (FDA) has issued a warning letter to East CK Trading Inc. (CMS# 721324) following inspections conducted between October 2023 and November 2025. The company was found to be in significant violation of the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) and section 805 of the FD&C Act. Specifically, East CK Trading Inc. failed to develop, maintain, and follow an FSVP for imported foods, including ginseng, wolfberry, and mushroom seasoning from specified foreign suppliers.
This warning letter signifies that East CK Trading Inc. is not in compliance with U.S. food safety standards for imported foods. Failure to adequately address these violations could result in further FDA action, including refusal of admission for imported foods and placement on detention without physical examination (DWPE) under Import Alert #99-41. The company must demonstrate corrective actions and provide supporting documentation to the FDA to resolve these compliance issues.
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