FDA WARNING_LETTER - Bhan Kanom Thai Inc - December 14, 2021

The FDA issued a Warning Letter to Bhan Kanom Thai Inc. following remote Foreign Supplier Verification Program (FSVP) inspections on December 6, 7, 9, 13, and 14, 2021, and an earlier inspection on July 19, 2021. The inspections aimed to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FSVP regulation (21 CFR part 1 subpart L).

The company was found to be non-compliant with FSVP requirements, specifically failing to develop, maintain, and follow an FSVP for any imported products, including "Cookie Rolls - Herbal," "(b)(4) Chip," and "(b)(4) Dipping Sauce." This violates 21 CFR 1.502(a) and section 805 of the FD&C Act.

Form FDA 483a, FSVP Observations, was issued after both inspections. While the company responded on August 3, 2021, stating intent to attend an FSVP class and achieve compliance by 2022, no response to the December 14, 2021, Form FDA 483a was received.

Failure to address these violations may lead to refusal of admission for imported food products under section 801(a)(3) of the