FDA WARNING_LETTER - Sunic's Food, Inc. d.b.a Sun Food Trading Company - May 21, 2010

On May 20-21, 2010, the FDA inspected Mr. Tan's seafood importer establishment at 4715 6th Avenue South, Seattle, Washington, and found a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. Specifically, the firm failed to implement an affirmative step to ensure imported frozen fish balls and fried fish cakes from (b)(4) were processed according to FDA's seafood HACCP regulations, violating 21 CFR 123.12(a)(2)(ii).

This violation renders the frozen fish balls and fried fish cakes adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), as they were prepared, packed, or held under insanitary conditions. The FDA may refuse admission of future imports under Section 801(a) of the Act, including "detention without physical examination," seize products, or enjoin the firm from further violations.

The firm must respond in writing within fifteen working days, outlining specific corrective actions, including documentation like HACCP and importer verification records. Failure to correct all violations must be explained with a timeline for completion. The letter emphasizes the firm's responsibility to ensure full compliance with the Act and