FDA WARNING_LETTER - AMO and Wing Inc. dba T and H Trading Co. - June 22, 2022
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On December 7, 2022, the FDA issued a Warning Letter to AMO and Wing Inc. dba T and H Trading Co. following Foreign Supplier Verification Program (FSVP) inspections on June 21-22, 2022, and May 18, 2021. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L.
The FDA found the company non-compliant with FSVP requirements for imported foods. Despite the company's claim of being a "very small importer" (VSI) and providing sales data, they failed to obtain required written assurances from foreign suppliers. Specifically, the company did not provide written assurances for dried noodles and dried bean curd from (b)(4) and vermicelli from (b)(4).
As a VSI, the company is required by 21 CFR 1.512(b)(3) to obtain written assurance from foreign suppliers, before importing and every two years thereafter, that food production meets U.S. food safety standards (Sections 418 or 419, and 402 and 403(w) of the FD&C Act).
Failure to address these violations may result in refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, detention
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