FDA WARNING_LETTER - Zhong Shun Inc. - December 13, 2011

On December 13, 2011, the FDA inspected Zhong Shun Inc.'s seafood importer establishment at 18605 Gale Ave., #245, City of Industry, CA 91748, 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 and fishery products.

The firm's frozen roasted eel was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), due to insanitary conditions.

Specific violations included: 1. Failure to have product specifications for imported frozen roasted eel from China, violating 21 CFR 123.12(a)(2)(i). 2. Failure to implement an affirmative step to ensure imported frozen roasted eel from China was processed in accordance with seafood HACCP regulations, violating 21 CFR 123.12(a)(2)(ii).

The FDA reminded the firm of its responsibility to hold imported products intact until released by the FDA and warned that distributing violative products could lead to seizure, injunction, or prosecution. Further actions, such as refusal of admission under Section 801