FDA WARNING_LETTER - 17 Merrill Drive LLC - December 20, 2013

On February 14, 2014, the FDA issued a Warning Letter to 17 Merrill Drive LLC, following an inspection from December 4-20, 2013. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110).

The firm's vacuum-packed refrigerated and frozen ready-to-eat (RTE) lobster meat, frozen RTE scored lobster claws, refrigerated RTE crabmeat, vacuum-packed frozen RTE crabmeat, and frozen RTE scored crab claws were deemed adulterated due to insanitary conditions. The FDA found that the firm's HACCP plans for these products lacked adequate critical limits for controlling pathogenic bacteria survival during cooking and growth/toxin formation during refrigerated storage. Specifically, cooking critical limits were not scientifically validated, and refrigerated storage critical limits allowed temperatures above the minimum growth for pathogenic bacteria.

Furthermore, the firm failed to implement monitoring procedures for cooler temperatures as outlined in their HACCP plans. Sanitation deficiencies were also noted, including condensation dripping from ceilings, rust and discoloration in ice chutes, and cleaning hoses in direct contact with wet processing room floors.

The FDA acknowledged the firm's response to the FDA 483 but deemed it inadequate due to a lack of supporting documentation, including complete HACCP plans. The letter advises the firm to review FDA