FDA WARNING_LETTER - Alma Reserve - November 09, 2020

From October 8 to November 9, 2020, the FDA conducted a remote Foreign Supplier Verification Program (FSVP) inspection for Alma Reserve, located at 138 Avenue U, Brooklyn, NY. This followed an earlier inspection on December 11, 2017. Both inspections aimed to assess compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FSVP regulation (21 CFR part 1 subpart L).

The FDA found Alma Reserve not in compliance with FSVP requirements for imported food products, including Fudge Candy, Cookies, and Rice Cakes from foreign supplier (b)(4). Specifically, Alma Reserve failed to develop, maintain, and follow an FSVP for these or any other imported foods, violating 21 CFR 1.502(a) and section 805 of the FD&C Act.

Following both the 2017 and 2020 inspections, the investigator issued a Form FDA 483a, FSVP Observations, but no response was received. The letter emphasizes that this is not an exhaustive list of violations.

Alma Reserve must take prompt action to correct these violations. Failure to do so may result in refusal of admission for imported food products under section 801(a)(3) of the FD&C Act (Import Alert #99-41) and prohibition of