FDA WARNING_LETTER - Kyawkhin Inc. - August 17, 2023

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Kyawkhin Inc. from August 15-17, 2023, to determine compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L. The inspection revealed significant violations, specifically that the firm failed to develop, maintain, and follow an FSVP for any imported foods, as required by section 805 of the FD&C Act and 21 CFR 1.502(a). This indicates a fundamental lack of a quality system to ensure imported foods meet U.S. safety standards. The firm had not responded to the Form FDA 483a issued at the inspection's conclusion. Kyawkhin Inc. is required to respond in writing within fifteen working days, detailing specific corrective actions, including providing documentation such as a copy of their FSVP and records demonstrating its implementation. Failure to adequately address these violations may result in further action, including refusal of admission for imported foods, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act. The FDA also noted that the firm might qualify as a "very small importer" under 21 CFR 1.500, which would entail modified FSVP requirements under 21 CFR 1.512.