PT. Tuna Permata Rezeki – FDA Warning Letter, Oct 22, 2010

On March 9, 2011, the FDA issued a Warning Letter to PT. Tuna Permata Rezeki following an inspection on October 21-22, 2010, which revealed deviations from the Seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 123). The inspection resulted in an FDA-483, and the firm's November 6, 2010 response, including a revised HACCP plan, was acknowledged.

The FDA determined the firm's tuna was adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions. Serious deviations included:

1. **Inadequate Hazard Analysis (21 CFR 123.6(a) and (c)(1)):** The revised HACCP plan for "Processing Of Frozen Tuna" did not list *Clostridium botulinum* growth and toxin formation as a hazard during the "Processing (Filleting, Skinning, Trimming, Cutting, Refrigeration and Packaging)" critical control point, despite products being held in sealed bags for extended periods. 2. **Missing Critical Limits (21 CFR 123.6(c)(3)):** The revised HACCP plan lacked a critical limit for "Decomposition" at the "Receiving raw material" critical