Savar Food Products, Inc. – FDA Warning Letter, Jan 31, 2014

On January 29-31, 2014, the FDA inspected Ocean Wave Products, Inc./Savar Food Products, Inc. and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), specifically 21 CFR 123.12 for imported fish. The firm failed to implement an affirmative step to ensure imported frozen Hilsa (shad) fish were processed in accordance with seafood HACCP regulations, violating 21 CFR 123.12(a)(2)(ii). This renders the Hilsa fish adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)).

The FDA warned that failure to correct these violations could lead to refusal of admission for imported products under Section 801(a) of the Act, including "detention without physical examination," product seizure, and/or injunction. The firm was required to respond in writing within fifteen working days, outlining specific corrective actions, including documentation of HACCP and importer verification records, and affirmative step performance. Delays must be explained with a timeline for completion. The FDA also noted that re-inspection fees might be assessed to cover costs related to verifying compliance.