FDA WARNING_LETTER - Tuna Paradise Co. Ltd. - August 08, 2017

On August 7-8, 2017, the FDA inspected Tuna Paradise Co., Ltd. in Thailand, revealing serious violations of the seafood HACCP regulation (21 CFR Part 123). The firm's tuna products are deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations include: 1. **Hazard Analysis Deficiencies (21 CFR 123.6(a) and (c)(1)):** The HACCP plan for histamine-forming fish failed to list *Clostridium botulinum* toxin formation as a reasonably likely food safety hazard for frozen, raw vacuum-packaged tuna steaks. 2. **Critical Control Point Omission (21 CFR 123.6(a) and (c)(2)):** The HACCP plan did not list unrefrigerated processing, including thawing, as a critical control point for controlling scombrotoxin (histamine) formation. 3. **Inadequate Critical Limits (21 CFR 123.6(c)(3)):** Critical limits at the "(b)(4)" critical control point were insufficient to control scombrotoxin formation from harvest vessel to transit. Specific recommendations for internal fish temperatures at offloading and during transit were provided. 4. **Insufficient Monitoring Procedures (21 CFR 123.6