FDA WARNING_LETTER - Hickory Smokehouse Miami, Inc. - April 07, 2011

On April 4-7, 2011, the FDA inspected Hickory Smokehouse Miami, Inc.'s seafood processing facility, revealing serious violations of seafood HACCP (21 CFR 123) and CGMP (21 CFR 110) regulations. The firm's cold smoked, cured, vacuum-packed, refrigerated, ready-to-eat salmon products were deemed adulterated due to insanitary conditions.

Key violations include: - **HACCP Plan Deficiencies:** Failure to continuously monitor cooler and smoke room temperatures as per the HACCP plan. Inadequate critical limits for smoking, not specific to various salmon fillet sizes. Insufficient monitoring procedures for curing and smoking, lacking validation for minimum curing times across all product sizes and monitoring of water phase salt (WPS) levels. - **Corrective Actions:** Inappropriate corrective action plan for curing, lacking scientific validation. Failure to take corrective action for 17 out of 43 processing days when curing and smoking times deviated from established schedules. - **CGMP Violations:** Failure to rinse acidified sodium chlorite solution from RTE smoked salmon products before packaging, contrary to the solution's technical data sheet. Inadequate monitoring of sanitation conditions, evidenced by employees handling RTE salmon with contaminated gloves, black residue on curing bins, and dusty packaging materials. - **Receiving Critical Limits:** Inadequate critical limits for receiving cured fish, relying solely on frozen gel packs without ensuring proper