FDA WARNING_LETTER - Contes Pasta Company, Inc. - February 16, 2011

On May 16, 2011, the FDA issued a Warning Letter to Contes Pasta Company, Inc. following an inspection from January 24, 2011, to February 16, 2011. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (GMP) regulations (21 CFR Part 110).

The primary violation cited was the failure to take appropriate corrective action when a deviation from a critical limit occurred in the thawing process for frozen lobster, specifically regarding *Clostridium botulinum* growth and toxin formation. On May 20, 2010, the "Thawing Log" indicated a temperature deviation for frozen lobster meat, but no corrective action was documented, and the product was subsequently used. This renders the seafood-filled pasta adulterated.

Additionally, the "Heart Shaped Lobster Ravioli (in red dough)" product was found to be misbranded under section 403(k) of the Act because it contains coloring (Yellow No. 6) that was not specifically declared in the ingredient statement, violating 21 CFR 101.22(k)(1).

The company's February 24, 2011, response to the FDA-483 was deemed inadequate, as it did not include