FDA WARNING_LETTER - Ottogi SF Corporation - July 13, 2011

On November 25, 2011, the FDA issued a Warning Letter to Ottogi SF Co. Ltd. following an inspection from July 11-13, 2011, at their South Korea facility. The inspection revealed serious deviations from low-acid canned food regulations (21 CFR Parts 108 and 113) and seafood HACCP regulations (21 CFR Part 123), rendering their canned tuna products adulterated under Section 402(a)(4) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Low-Acid Canned Food (LACF) Deviations:** * **Processing Method:** The firm processed canned tuna using gravity-filled jumble-loaded retort baskets, contrary to their filed thermal processes stating the use of divider plates. Their submitted study regarding this change was deemed insufficient. * **Initial Temperature Recording:** Failure to determine and record the initial temperature of container contents prior to processing, as required by 21 CFR 113.87(c). * **Container Coding:** Failure to mark each sealed container with a code identifying the establishment, product, year, day, and period packed (21 CFR 113.60(c)). Only an expiration date was identified. * **Qualified Personnel:** Operators of retorts and persons performing container closure examinations were not supervised by an