Stavis Seafoods, LLC

WARNING LETTER Stavis Seafoods, LLC MARCS-CMS 727785 — April 15, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Food & Beverages Recipient: Recipient Name Juan Lopez Martinez Recipient Title CEO Stavis Seafoods, LLC 1 Seafood Way Boston , MA 02210-2702 United States (b)(6), (b)(7)(C) Issuing Office: Office of Inspections and Investigations United States 04/15/2026 WARNING LETTER RE: CMS# 724267 Dear Mr. Martinez: On February 03, 2026, through February 05, 2026, the Food and Drug Administration (FDA) conducted an inspection of your seafood importer establishment, Stavis Seafoods, LLC located at 1 Seafood Way, Boston, MA 02210-2702. We also conducted an inspection from June 11 through June 13, 2024. We found that you have 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 inspection identified serious violations for 21 CFR Part 123, your frozen aquaculture salmon fillets 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. Your significant violations are as follows: You do not have or have not implemented an affirmative step for ensuring that fish and fishery products you import are processed in compliance with the Seafood HACCP regulation, as required by 21 CFR 123.12(a)(2)(ii). Specifically, your firm did not implement an affirmative step for ensuring that the frozen aquaculture salmon fillets you import from (b)(4) located in (b)(4) are processed in compliance with the Seafood HACCP regulation. 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 to Food and Drug Administration, Attention: Jananiga Vanniyasingam, Compliance Officer, Division of Northeast Imports: oiioiodneiwlresponses@fda.hhs.gov. Please also cc (carbon copy) Jananiga.vanniyasingam@fda.hhs.gov. If you have any questions regarding this letter, you may contact Compliance Officer Vanniyasingam via email at Jananiga.vanniyasingam@fda.hhs.gov. Please reference CMS# 724267 on any documents or records you provide to us and on the subject line of any email correspondence you send to us. Sincerely, /S/ CDR Joseph S. Tomao Program Division Director Division of Northeast Imports Content current as of: 06/02/2026 Regulated Product(s) Food & Beverages