FDA WARNING_LETTER - New Tiao Peng Trading, Inc. - January 17, 2020
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The FDA issued a Warning Letter to Tiao Peng Trading, Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted on January 14-17, 2020, with a prior inspection on September 12, 2017. The inspections revealed significant non-compliance with section 805 of the Federal Food, Drug, and Cosmetic Act and the implementing FSVP regulation (21 CFR part 1 subpart L). The firm failed to develop, maintain, and follow FSVPs for several imported foods, including canned beans, fruit, fish snacks, and custard cake. For low-acid canned foods like curry gravy, the company did not verify production according to 21 CFR part 113. Additionally, Tiao Peng Trading, Inc. did not document foreign supplier approval (21 CFR 1.505(b)), lacked written procedures for approving suppliers (21 CFR 1.506(a)(1)), failed to establish adequate written procedures for verification activities (21 CFR 1.506(b)), and did not conduct or document required supplier verification activities (21 CFR 1.506(e)) for products like pickled mustard, tom yum soup paste, and curry gravy. The FDA acknowledged the firm's January 27, 2020 response but found it inadequate due to a lack of supporting documentation. The company must promptly correct these violations and provide a written response with supporting evidence within fifteen working days. Failure to comply could result in refusal of admission for imported products, detention without physical examination, and prohibition of importation.
- Company
- New Tiao Peng Trading, Inc.
- Inspection Date
- January 17, 2020
ID · 231fa8c5-b42f-41dd-81f0-4160fb3b6223
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