best seasonings group inc. – FDA Warning Letter, Dec 20, 2012

The FDA inspected Best Seasonings Group Inc.'s seafood manufacturing establishment in Juana Diaz, Puerto Rico, from December 4-20, 2012. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their "El Rey Salmorejo de Jueyes" (Crabmeat stew) product adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The primary violation was the firm's failure to have and implement a written HACCP plan for "El Rey Salmorejo de Jueyes" to control food safety hazards like *Listeria monocytogenes* growth. Although the firm submitted a response on December 27, 2012, with a newly developed HACCP plan, it was deemed inadequate. Deficiencies included: no specified implementation date for the new plan; failure to identify "Cooling" as a Critical Control Point (CCP) for the fully cooked product; lack of evidence that the HACCP plan was developed by a qualified individual (21 CFR § 123.10); failure to identify pathogenic bacteria growth (e.g., *Listeria monocytogenes*) as a hazard during the "Cooling" step; and omission of undeclared allergens as a potential food safety hazard in the Hazard Analysis, requiring a labeling CCP.