FDA WARNING_LETTER - Shantaba LLC - July 07, 2023

The FDA issued a Warning Letter to Shantaba LLC following a Foreign Supplier Verification Program (FSVP) inspection conducted from June 30 to July 7, 2023, with a previous inspection on June 8-9, 2021. The inspection determined non-compliance with Section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and 21 CFR Part 1, Subpart L, which mandates importers perform risk-based activities to verify imported food meets U.S. food safety standards.

The significant violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, including "2-Minute Noodles," "Kesar Mango Pulp," and "Soya Wadi-Soya Chunks." A Form FDA 483a FSVP Observations was issued on July 7, 2023, to which no response was received.

Failure to address these violations may result in further FDA action, including refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, placement on detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under Section 301(zz) of the FD&C Act. Shantaba LLC must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation (e.g., a copy of their