Mamma Lina's, Inc. – FDA Warning Letter, Apr 1, 2010

On June 7, 2010, the FDA issued a Warning Letter to Mamma Lina's, Inc. following an inspection from March 30 to April 1, 2010. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice (CGMP) regulation (21 CFR Part 110). As a result, the firm's Lobster Ravioli, Seafood Ravioli, and Argentinean Style Tuna filled Empanadas were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Key violations included: 1. **Inadequate HACCP Plan Monitoring Frequency:** The revised HACCP plan for Lobster and Seafood Ravioli lacked an appropriate monitoring frequency for the post-cooking cool-down critical control point to control *Staphylococcus aureus* growth. The listed frequency of "every (b)(4) hours" was insufficient for the specified cooling critical limits. 2. **Inappropriate Corrective Actions:** The HACCP plans for Lobster Ravioli, Seafood Ravioli, and Tuna Empanadas had inappropriate corrective actions for metal detection and undeclared sulfites, as they did not address correcting the cause of the deviations. 3. **Failure to Implement Record Keeping:** The firm did not record monitoring observations at the "Finished