FDA WARNING_LETTER - Grindstone Neck of Maine, LLC - August 10, 2012

On September 18, 2012, the FDA issued a Warning Letter to Grindstone Neck of Maine, LLC, following an inspection from July 30 to August 10, 2012. The inspection revealed serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 110).

The firm's ready-to-eat (RTE) vacuum-packed cold smoked mussels were deemed adulterated due to insanitary conditions. Specific violations included inadequate critical limits in HACCP plans for RTE vacuum-packed cold smoked mussels and cured Gravlax wild salmon, lacking validation studies and recent water phase salt level analyses. The firm also failed to identify *Clostridium botulinum* as a significant hazard for cold smoked mussels.

Monitoring procedures were not implemented, as evidenced by the absence of a continuous temperature monitoring device in cooler #2 where RTE cold smoked mussels were stored. Sanitation conditions were deficient, with observations of pests (bats, flies, spiders), cross-contamination risks (improper cleaning, lack of handwashing), undetectable sanitizer concentration, unlabeled toxic compounds, and inadequate protection of packaging from adulterants. The exterior well cap, protecting the water supply, was unlocked.

Furthermore, the firm failed to maintain sanitation control records for five key areas: water safety, protection from adulteration, toxic chemical