FDA WARNING_LETTER - Greenhead Lobster Products LLC - October 06, 2021

The FDA inspected a ready-to-eat (RTE) seafood processing facility in Bucksport, ME, from September 21 to October 6, 2021. The inspection revealed the presence of *Listeria monocytogenes* (L. monocytogenes) in environmental samples, including a floor drain cover near the picking/cracking station. Additionally, the firm's internal environmental monitoring detected 13 recurring L. monocytogenes positives on food-contact surfaces and the cooling tank between May and August 2021. These findings indicate inadequate control of L. monocytogenes, leading to the adulteration of RTE cooked lobster products.

The facility also had serious violations of the Seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123). The HACCP plan for RTE vacuum-packed cooked lobster meat had an inadequate monitoring frequency for the cooking critical control point, failing to ensure a 6-log reduction of L. monocytogenes. The firm's cooking process monitoring records routinely showed non-compliance with established critical limits for starting lobster temperature, steam tunnel chamber temperature, and belt speed/cooking time.

Furthermore, the firm failed to adequately monitor sanitation conditions. Condensate buildup was observed on the ceiling above exposed RTE cooked lobster meat, and an evaporator catch-bucket overflowed onto the cooler floor, a repeat observation.

The firm provided responses and corrective actions, including a voluntary