Sobh Import, Inc. – FDA Warning Letter, Mar 29, 2021

On March 22-29, 2021, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection of Sobh Imports, Inc., following a previous inspection on November 6, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L. The FDA found that Sobh Imports, Inc. was not in compliance with FSVP requirements for any products imported, including Lokum Biscuit, Sugar-Coated Pistachios, and Nougat with Cardamon. Specifically, the firm failed to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). The firm's April 12, 2021, response, indicating plans to attend an FSVP class, was deemed insufficient. Failure to adequately address these violations may lead to refusal of admission for imported food products under section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under section 301(zz). Sobh Imports, Inc. must respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation, such as copies of implemented FSVP records.