FDA 483 - Haifa Smoked Fish - June 24, 2004

The FDA Form 483 details numerous deficiencies at a seafood processing facility. The facility lacks a written HACCP plan for vacuum-packed and air-packed cold smoked Golden Brook Trout to control *Clostridium botulinum* and pathogen growth, and does not monitor or record product temperature during processing and storage. Continuous monitoring of the finished product cooler is absent.

The HACCP plan for refrigerated, vacuum-packaged, cured/smoked ready-to-eat fish omits processing as a critical control point for pathogen growth. Observed temperature abuses include: eviscerating room at 68.9°F, rinse water at 54.5°F, fish in rinse water at 50°F, and brining cooler at 48°F. Cold smoked mackerel and capelin were held at elevated temperatures (46.2°F to 66°F) for extended periods outside refrigeration. Vacuum-packed cold smoked salmon was left on a loading dock at 70.7°F for over 3 hours. Dried salt-cured whitefish and capelin were air-dried in an unrefrigerated room at 52°F, with internal fish temperatures reaching 68-70°F.

The facility failed to implement corrective actions for temperature deviations, such as cold smoked products processed above the maximum critical limit. The HACCP plan does not list *Clostridium botulinum* as a hazard at brining