Alma Reserve

Warning LetterOpen

Alexander Tkach President Alma Reserve 138 Avenue U Brooklyn , NY 11223 United StatesFEI 3008276195Issued Jan 19, 2021Division of Northeast Imports

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3008276195.

Letter Details

Firm: Alma Reserve
Location: Alexander Tkach President Alma Reserve 138 Avenue U Brooklyn , NY 11223 United States
FEI Number: 3008276195
Country: United States
Issue Date: January 19, 2021
Issuing Office: Division of Northeast Imports
Product Type: Other
Status: Open

Summary

Alma Reserve, a food and beverage importer based in Brooklyn, NY, failed to establish Foreign Supplier Verification Programs (FSVP) for imported food products including Fudge Candy, Cookies, and Rice Cakes, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1 subpart L. The company had not developed, maintained, or followed any FSVP for the foods it imported despite receiving FDA Form 483a observations during an initial inspection in December 2017 and a follow-up remote inspection in November 2020, and failed to respond to either observation. These violations represented significant non-compliance with requirements mandating importers perform risk-based activities to verify that imported human food meets applicable U.S. food safety standards.