FDA WARNING_LETTER - The Smokehouse, LLC. d/b/a La Maree Smokehouse - April 01, 2011

The FDA inspected The Smokehouse, LLC. d.b.a. La Maree Smokehouse in Mamaroneck, NY, from February 23 to April 1, 2011. The inspection revealed the presence of *Listeria monocytogenes* (L. monocytogenes) in refrigerated ready-to-eat cold smoked salmon and on environmental swabs from the facility, rendering products adulterated under 21 U.S.C. §342(a)(1) and (a)(4). Six environmental swabs tested positive for *L. monocytogenes*, including from a cutting board, floor drains, and a dustpan. PFGE analysis showed the *L. monocytogenes* isolates from the salmon and environmental swabs were indistinguishable, suggesting widespread contamination due to inadequate sanitation.

The firm also had 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). HACCP plan deficiencies included failure to list scombrotoxin (histamine) as a hazard, inadequate monitoring procedures and frequencies for critical control points (e.g., lack of temperature monitoring for *C. botulinum* control, insufficient monitoring frequency for refrigerated storage), and inappropriate corrective actions that did not address the root cause of deviations. Sanitation violations included corroded and rusting metal on plastic trays in contact with raw