FDA WARNING_LETTER - Morey's Seafood International, LLC - February 07, 2008

The FDA inspected Morey's Seafood International, LLC's facility from January 28 to February 7, 2008, and found serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123), Current Good Manufacturing Practice (GMP) regulations (21 CFR Part 110), and Food Labeling regulations (21 CFR Part 101).

The Hot Smoked Fish and Frozen Fish Fillets Marinated products were deemed adulterated due to insanitary conditions. Specific sanitation deficiencies included: lack of backflow prevention devices on hose bibs in multiple processing areas; totes for finished product containing residual water and old product buildup; and employees handling ready-to-eat items after touching insanitary objects without handwashing. Additionally, a marinade kettle was covered with cardboard placed on the floor, and spray from cleaning tables splashed into uncovered marinade.

HACCP plan violations included: failure to list a critical control point for sulfites in Hot Smoked Fish and Frozen Fish Fillets Marinated, despite an ingredient containing sulfites; and failure to list "Cooling" as a critical control point for pathogen growth in Hot Smoked Fish, as the holding area was not refrigerated and time/temperature were not monitored before blast freezing.

Labeling violations for Morey's Marinated Salmon Lemon Dill included: misbranding due to undeclared major food allergens (wheat and milk) present in