FDA WARNING_LETTER - P&S; Ravioli Company - January 16, 2015

On August 4, 2015, the FDA issued a Warning Letter to P&S Ravioli Company following an inspection from January 7-16, 2015. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Points (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).

The Lobster Ravioli product was deemed adulterated due to insanitary conditions. Additionally, Jumbo Lobster Ravioli, Cheese Tortellini, Linguine, Alfredo Sauce, and Tomato Sauce products were found to be misbranded under 21 CFR Part 101.

Key violations included: - **HACCP Deficiencies:** Failure to list *Clostridium botulinum* growth and toxin formation as a hazard for Lobster Ravioli, inadequate corrective actions for temperature deviations, failure to list "Finished Product Labeling" as a Critical Control Point for allergen control, and non-implementation of continuous temperature monitoring for the walk-in refrigerator. Repeat deficiencies from 2009 and 2010 inspections were noted. - **Sanitation Control Records:** Failure to maintain records for handwashing/toilet facilities, protection from adulteration, and proper labeling/storage of toxic compounds. - **Sanitation Deviations:** Improper cleaning methods (high-pressure air near exposed food), employees wearing unsecured jewelry, and lack of beard