Nyumbani Hakuna Matata LLC

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December 23, 2024

WARNING LETTER

Re: CMS # 699085

Dear: Jacques B. Waciba,

We inspected your seafood importer establishment, located at 189 Hertel Ave., Buffalo, NY, 14207 on 11/13/2024 and we conducted an initial inspection on 08/24/2023. Our initial inspection on 08/24/2023, resulted in your firm receiving a letter from FDA dated 09/24/2023, that explained your firm’s non-compliance with the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations Part 123 (21 CFR Part 123). This current follow-up inspection found that no corrections were made from the initial inspection, and you had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry.

Because our inspections identified serious violations for 21 CFR Part 123, your dried Nile Perch, dried Lake Tanganyika Dagaa (Sprat) and dried Migebuka (Perch) are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.

We acknowledge your email response dated 12/02/2024, that consisted of you acknowledging the violations noted during our inspection that concluded on 11/13/24 and a statement that you will be complying; however, this response has been deemed inadequate.

Your significant violations were as follows:

You do not have or have not implemented written verification procedures, product specifications and an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation. Specifically, you have not implemented written procedures, product specifications and an affirmative step for the Dried Nile perch (Lates niloticus), Dried Lake Tanganyika Dagaa (Stolothrissa tanganicae) and Dried Migebuka (Lates stappersii) that you import from Tanzania for ensuring the fish are processed in compliance with the Seafood HACCP regulation, to comply with 21 CFR 123.12(a)(2)(ii).

We may take further action if you do not promptly correct these violations. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act (21 U.S.C. § 381(a)), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.

You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.

This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.

Please send your reply or if you have any questions regarding this letter via email to the Food and Drug Administration, Attention: Julie Scoma, Compliance Officer, julie.scoma@fda.hhs.gov, please reference CMS #699085 on any documents or records you provide and/or within the subject line of the email.

Sincerely,
/S/

Keith J. Jasukaitis
Program Division Director
Division of Northern Border Imports