FDA 483 - D & M Smoked Fish, Inc. - June 28, 2001

This FDA Form 483, issued to Haifa Smoked Fish, Inc., a smoked fish manufacturer located at 94-15 150th Street, Jamaica, N.Y. 11435, details observations from an inspection conducted from June 5-28, 2001. Mr. Arcadi Marcovich, President, was the recipient.

The inspection revealed several violations related to the firm's HACCP plan and manufacturing practices. The HACCP plan for hot and cold smoked fish products failed to identify the rinse step as a critical control point for achieving adequate water phase salt levels (minimum 0.10) to control *Clostridium botulinum* type-E. The firm also failed to follow thawing specifications for cold smoked mackerel batches; their SOP involved defrosting uneviscerated frozen fish overnight in an unrefrigerated main processing room at ambient temperatures, contrary to their process schedule's guideline of defrosting in a walk-in cooler below 38°F. The HACCP plan for cold smoked fish was inadequate as it did not recognize *Clostridium botulinum* Type-E in the gut of uneviscerated fish as a hazard during thawing. Furthermore, the critical limit for finished product storage in the HACCP plan was inadequate, lacking a maximum time limit for exposure to temperatures between 38°F and 50°F, despite *Clostridium botulin