FDA 483 - Raifa Smoked Fish, Inc. - January 31, 2001

On January 23, 24, 30, and 31, 2001, an FDA inspection was conducted at Raifa Smoked Fish, Inc., a smoked fish processor located at 94-15 150th St., Jamaica, NY. The inspection revealed eleven observations regarding the firm's operations and HACCP plan.

Key violations include: 1. **HACCP Plan Deficiencies:** The firm's HACCP plan failed to recognize histamine formation as a significant hazard during the receiving and thawing of scombrotoxin-forming fish. It also did not list various fish species covered by the plan. 2. **Monitoring Inconsistencies:** The thawing log only recorded temperatures once, despite the HACCP plan indicating more frequent monitoring ("...and times interim or more as per experience"). 3. **Record-Keeping Errors:** The Brining/Dry Salting Log incorrectly recorded the date instead of the required "Time - out of brine/dry salting." 4. **Cross-Contamination Risks:** Finished smoked fish products were stored in the same refrigerator as raw brining fish. Additionally, on 1/24/01, wooden pallets with finished smoked mackerel were stored directly on top of tanks containing raw brining fish. 5. **Unprotected Products:** Unpackaged and uncovered nova was stored on racks in the refrigerator. 6. **Facility and Hygiene Issues:** The ev