FDA WARNING_LETTER - Manolo and Son, LLC - March 15, 2011

On March 9-15, 2011, the FDA inspected Manolo and Son, LLC's seafood processing facility and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The firm's canned pasteurized crabmeat was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions.

Key violations included an inadequate HACCP plan for canned pasteurized crabmeat. The plan's monitoring procedure for pathogen growth and toxin formation at a critical control point was insufficient, lacking specific temperature monitoring during transportation or continuous monitoring/recording of ambient air temperature during storage. The monitoring frequency was also deemed inadequate. Furthermore, the firm's corrective action plans at two critical control points were not appropriate, failing to ensure the cause of deviation is corrected or that adulterated product does not enter commerce.

The FDA noted that the firm was unable to provide temperature monitoring records for the cooler during the inspection. A March 22, 2011, response from the firm to the FDA-483 was deemed inadequate, as it failed to address receiving and cold storage critical control points, monitoring procedures, corrective actions, verification procedures, and record-keeping.

Manolo and Son, LLC was required to notify the FDA in writing within fifteen working days of the specific steps taken to correct the violations,