Tuty USA LLC – FDA Warning Letter, Apr 14, 2021

Tuty USA LLC received an FDA Warning Letter following a remote Foreign Supplier Verification Program (FSVP) inspection conducted from March 29 to April 14, 2021, which followed a prior inspection on November 7, 2018. The inspection revealed significant violations of section 805 of the Federal Food, Drug, and Cosmetic Act and the implementing FSVP regulation (21 CFR part 1 subpart L). Specifically, the firm failed to develop, maintain, and follow an FSVP for any imported food products, including wheat snacks, Japanese peanuts, and Blackberry Tartlet Cookies, as required by 21 CFR 1.502(a). The FDA acknowledged the firm's April 15, 2021, response indicating efforts to implement the program but noted the absence of detailed plans or a timeframe. The letter mandates a written response within fifteen working days, outlining specific corrective actions, providing supporting documentation, and explaining any delays. Failure to adequately address these violations may lead to severe business implications, including refusal of admission for imported food products, 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 emphasized the firm's responsibility to ensure overall compliance with food safety laws.