FDA 483 - D & M Smoked Fish, Inc. - October 07, 2005

This FDA Form 483 details significant deficiencies in the implementation and maintenance of the HACCP plan for a facility producing refrigerated, vacuum-packaged, cured, and cured/smoked ready-to-eat fish.

**Key Violations and Observations:**

* **HACCP Plan Implementation Failure:** The facility failed to implement monitoring, recordkeeping, and verification procedures as outlined in its HACCP plan. * **Brining (CCP):** No records of salinometer readings were maintained. * **Smoking/Drying/Cooking (CCP):** * Temperature recorder charts for cold smoking monitored internal fish temperature instead of smokehouse temperature and time. * Numerous temperature recording charts were illegible, inaccurate (showing incorrect start times), or missing for critical processing periods (e.g., lots SL258, M248I, II, III, WFC248II, WFC249I, WFC249II, SL236). * Temperature recording devices in smoking ovens had not been calibrated for approximately two years. * **Packaging/Labeling (CCP):** A packing log, required by the HACCP plan, was not maintained. * **Record Review Deficiencies:** * Brining logs lacked supervisory review (signature and date) for the actual duration of brining. * Critical control point monitoring