FDA 483 - D & M Smoked Fish, Inc. - July 05, 2006

The FDA inspection of a seafood processing facility revealed significant deviations from HACCP plan requirements and Good Manufacturing Practices (GMPs).

**HACCP Plan Deficiencies:** * **Monitoring:** The facility failed to monitor brine strength with a salinometer for cold-smoked products, as required. Temperature recording charts for cold-smoke CCP monitored internal fish temperature instead of ambient oven temperature. * **Recordkeeping:** Shipper guarantees for freezing parameters and product temperature logs for in-process/finished product cold storage were not maintained. * **Verification:** Records for oven thermometer calibration were absent. Processing, receiving, and brining/dry curing records lacked signatures and dates for required reviews. * **Corrective Actions:** The facility did not implement corrective actions or determine the cause of deviations for both hot and cold-smoked seafood products. Several instances of critical limit deviations were observed for cold-smoke and hot-smoke CCPs (e.g., mackerel, whitefish, paddlefish, seabass processed outside temperature/time limits) with no corrective action taken before product shipment. A cooler temperature deviation (49°F vs. 40°F limit) was noted without corrective action. * **Missing HACCP Plan:** No written HACCP plan existed for ready-to-eat whole (gutted) Herring in Brine (vacuum packed) and Herring in Oil to control *Clostridium Botulinum*, parasites, and histamine. *