NEM Advisors LLC / Shop & Save Market – FDA Warning Letter, Jan 26, 2021

On April 15, 2021, the FDA issued a Warning Letter to NEM Advisors LLC / Shop & Save Market following remote Foreign Supplier Verification Program (FSVP) inspections conducted from January 21-26, 2021, and previously on July 29, 2019. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 Subpart L.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, including Bread Mix, Dough Bread Mix, and Farmer’s Cheese. This directly violates 21 CFR 1.502(a) and Section 805 of the FD&C Act. While the company provided FSVP training certificates, they did not provide context for the individuals or actual FSVPs for imported foods.

The FDA noted that Farmer’s Cheese, a ready-to-eat product, presents a reasonable probability of serious adverse health consequences or death due to potential microbiological hazards like Salmonella, pathogenic E. coli, L. monocytogenes, S. aureus, and Clostridium botulinum.

Failure to address these violations may lead to refusal of admission of imported food products under Section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41