FDA WARNING_LETTER - NYUMBANI HAKUNA MATATA LLC - November 13, 2024

On December 23, 2024, the FDA issued a Warning Letter to Jacques B. Waciba, owner of a seafood importer establishment at 189 Hertel Ave., Buffalo, NY. This letter follows an inspection on November 13, 2024, which was a follow-up to an initial inspection on August 24, 2023. The initial inspection resulted in a September 24, 2023 letter notifying the firm of non-compliance with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123.

The follow-up inspection revealed no corrections were made, and serious violations of 21 CFR Part 123 persist. Specifically, the firm failed to implement written verification procedures, product specifications, and an affirmative step to ensure imported fish and fishery products comply with the Seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii). This applies to Dried Nile Perch, Dried Lake Tanganyika Dagaa (Sprat), and Dried Migebuka (Perch) imported from Tanzania.

Due to these violations, the imported products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as