Southwest Traders, Inc. – FDA Warning Letter, Aug 4, 2011

On August 1-4, 2011, the FDA inspected Southwest Traders, Inc.'s seafood processing facility in Dallas, Texas, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). These violations render their refrigerated tuna fish salad adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Inadequate Hazard Analysis:** The HACCP plan for "Seafood (fresh)" did not list scombrotoxin (histamine) as a reasonably likely food safety hazard for refrigerated tuna fish salad (21 CFR 123.6(a) and (c)(1)). While the firm stated they added it, no revised documentation was provided. 2. **Missing Critical Control Point:** The "Seafood (fresh)" HACCP plan failed to list receiving as a critical control point for refrigerated tuna fish salad (21 CFR 123.6(a) and (c)(2)). The firm claimed to have added it, but no supporting documentation was submitted. 3. **Inadequate Monitoring Frequency:** The HACCP plan's monitoring frequency for CCP 1B (Product Storage Refrigeration) was insufficient to control scombrotoxin (histamine), lacking immediate access to continuous temperature monitoring data (21 CFR 123.6