FDA WARNING_LETTER - Crystal Cove Seafood / Pt. Panca Mitra Multiperdana - November 05, 2009

On October 30 and November 5, 2009, an FDA inspection of Crystal Cove Seafood Corporation, a U.S. importer, revealed they were importing Frozen Cooked Shrimp from P. T. Panca Mitra MultiPerdana. The FDA collected a copy of P. T. Panca Mitra MultiPerdana's HACCP plan for "Frozen Cooked Shrimp," which showed serious deviations from the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. This renders the imported shrimp adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Specifically, the HACCP plan for "Frozen Cooked Shrimp" lacked adequate critical limits at the "Cooking" and "Cooling" critical control points. At the "Cooking" critical control point, the plan did not list a critical limit value for "Time" to control "Bacteria," and the reference to "Time/RPM" was insufficient. The FDA recommends a 6D process for Listeria monocytogenes inactivation and a study to verify cook process adequacy, monitoring cooker temperature and cook time. The significant hazard should be identified as "pathogen survival through cooking."

At the "Cooling" critical control point, the plan lacked adequate critical limits to control "Bacteria," specifically a critical limit for monitoring residual chlorine or other water sanitizer in the ice water bath. The FDA recommends including this