FDA WARNING_LETTER - Kerry Inc. - February 21, 2019

The FDA inspected Kerry, Inc.'s Fort Worth facility from February 11-21, 2019, uncovering serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). As a result, the firm's seafood soups are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Despite the firm's response to initial FDA 483 observations, further review identified additional deficiencies. Key violations include the failure to conduct a proper hazard analysis and establish a HACCP plan with critical control points for hot filling and container sealing operations, as mandated by 21 CFR 123.6(a) and (c)(2). Specifically, the firm did not monitor fill temperature during hot filling or ensure container closures were not defective, posing a risk of pathogenic bacteria introduction. Furthermore, the HACCP plan lacked adequate monitoring procedures and frequencies for the Cooking CCP to control pathogenic survival, violating 21 CFR 123.6(c)(4). The FDA warns of potential product seizure or an injunction if these violations are not promptly corrected. Kerry, Inc. must respond within fifteen working days, detailing specific corrective actions and providing supporting documentation. The firm is also responsible for adhering to GMP regulations and may incur re-inspection fees.