lacausa inc. – FDA Warning Letter, May 4, 2015

On May 4, 2015, the FDA inspected LaCausa, Inc., dba Kim Nguan Trading, a seafood importer, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Specifically, the firm failed to have or implement written verification procedures, product specifications, and an affirmative step to ensure imported fish are processed in compliance with the Seafood HACCP regulation, as required by 21 CFR 123.12(a)(2). This deficiency was noted for Prepared Anchovy, Prepared Soft Herring, and Prepared Cuttlefish products. Consequently, these products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, as they may have been prepared, packed, or held under insanitary conditions. The FDA warns that further action may be taken, including refusal of admission, detention without physical examination, seizure, or injunction. The firm must respond in writing within fifteen working days, outlining specific corrective actions, including HACCP and importer verification records, and documentation of affirmative steps. Failure to comply could result in severe business and operational implications, as the firm is responsible for ensuring compliance with all applicable regulations for imported seafood.