Conservas Ortiz S.A. – FDA Warning Letter, Feb 16, 2022

The FDA issued a Warning Letter to Poligono Industrial La Estacion following an inspection from February 14-16, 2022, which revealed serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's canned tuna products are deemed adulterated.

Key violations include: 1. **Inadequate HACCP Plan - Critical Control Points (CCPs):** The HACCP plan for "CANNED TUNA PRODUCTS" failed to list CCPs for scombrotoxin (histamine) formation at the "(b)(4)" step after "(b)(4)," and for *Staphylococcus aureus* growth and toxin formation at multiple post-cooking steps until retorting. 2. **Inadequate HACCP Plan - Critical Limits:** The plan lacked a critical limit for measuring internal fish temperatures when offloaded from harvest vessels at the "Fresh Fish and Frozen Fish reception CCP1 and CCP3" to control scombrotoxin. 3. **Inadequate HACCP Plan - Inadequate Critical Limits:** Critical limits for scombrotoxin control at the "(b)(4)" CCP (sensory examination) and the "(b)(4)" CCP (combining refrigerated and unrefrigerated processing) were insufficient. 4. **Inadequate HACCP Plan - Monitoring Procedures:** The monitoring frequency for undeclared allergens at the "(b)(4)"