FDA WARNING_LETTER - East CK Trading Inc. - November 25, 2025
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The FDA issued a Warning Letter to East CK Trading Inc. following inspections conducted from October 17, 2025, to November 25, 2025, with previous inspections dating back to September 2023. The company, based in Long Island City, NY, was found to be in significant non-compliance with the Foreign Supplier Verification Program (FSVP) regulation, which falls under section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. The core violation highlighted was the company"s failure to develop, maintain, and implement an FSVP for foods imported into the United States. Specifically, the company lacked proper programs for products such as Ginseng from Amazing International Trade (Dalian) Co. Ltd., Wolfberry from Gui Nan Hong Co. Ltd., and Mushroom Seasoning from Anhui Qiangwang Flavouring Food Co. Ltd. These regulations require importers to perform risk-based activities to ensure that imported foods meet U.S. food safety standards. The FDA deemed the company"s prior response inadequate due to a lack of supporting documentation for proposed corrective actions. East CK Trading Inc. must respond within fifteen working days, providing detailed corrective measures and supporting documentation, including a copy of their developed FSVP and records demonstrating its implementation. Failure to comply could result in severe actions, such as the refusal of admission for imported foods and their placement on detention without physical examination.
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