S&S Quality Wholesale Inc. – FDA Warning Letter, Feb 16, 2022

On June 1, 2022, the FDA issued a Warning Letter to S&S Quality Wholesale Inc. following a Foreign Supplier Verification Program (FSVP) inspection conducted from February 14-16, 2022, and a previous inspection on April 16, 2020. The inspection revealed significant violations of section 805 of the Federal Food, Drug and Cosmetic Act (FD&C Act) and the implementing FSVP regulation (21 CFR part 1 subpart L).

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported food products, as required by 21 CFR part 1.502(a). The company was issued a Form FDA 483a, FSVP Observations, on February 16, 2022, but no response was received.

Failure to address these violations may result in further FDA action, including refusal of admission of imported foods under section 801(a)(3) of the FD&C Act, and potential detention without physical examination (DWPE) under Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under section 301(zz) of the FD&C Act.

S&S Quality Wholesale Inc. must respond in writing within fifteen working days, detailing corrective actions, providing supporting documentation (e.g.,