FDA WARNING_LETTER - Ben E Keith Company - Selma - December 06, 2012

On November 27 to December 6, 2012, the FDA inspected Ben E. Keith Company's seafood processing facility in San Antonio, Texas, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). This renders their canned crabmeat, lump crabmeat, seafood salads, and fresh tuna adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Despite a December 20, 2012, response and revised HACCP plans received February 12, 2013, complete corrections were not made. Significant violations include: * **Inadequate Hazard Analysis:** HACCP plans for canned/lump crabmeat failed to list pathogenic bacteria growth and toxin production, and the fresh tuna plan omitted scombrotoxin (histamine) formation. * **Insufficient Critical Limits:** Receiving and storage critical limits for crabmeat, tuna, and seafood salads were inadequate or incomplete (e.g., missing transit temperature records, incomplete temperature logs, lack of "completely surrounded by ice" for tuna, and insufficient ambient temperature limits for seafood salads). * **Inadequate Monitoring Procedures:** Fresh tuna and seafood salads HACCP plans listed insufficient monitoring procedures and frequencies for storage critical control points (e.g., recommending continuous temperature monitoring or ensuring fish are completely surrounded by ice). *