FDA WARNING_LETTER - Trangs Group USA Incorporated - January 26, 2026

The FDA issued a Warning Letter to Trangs Group USA Incorporated following an inspection conducted from January 13 to January 26, 2026. The inspection evaluated the company"s adherence to the Foreign Supplier Verification Program (FSVP) regulation, which is detailed in section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. This regulatory framework mandates that importers establish risk-based processes to ensure their imported food products comply with United States food safety standards.

The primary violation identified was the company"s failure to develop, maintain, and consistently follow an adequate FSVP for imported foods, specifically citing "Frozen Bao Mini Mushroom Teriyaki Bun." Although Trangs Group USA submitted documentation in response to initial observations, the FDA deemed these submissions insufficient and not applicable to forming a proper FSVP for the identified products.

Trangs Group USA is now required to provide a written response within fifteen working days, detailing the precise corrective actions being implemented to address these significant violations. The response must include supporting documentation, such as a copy of their revised FSVP and records demonstrating its effective implementation. Failure to resolve these issues appropriately could result in serious consequences, including the refusal of admission for imported foods into the U.S. and their placement on detention without physical examination.