FDA WARNING_LETTER - Service Smoked Fish Corp - November 27, 2009

The FDA inspected Service Smoked Fish Corp. from November 5-27, 2009, identifying serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations. The firm's cold smoked, ready-to-eat seafood products are deemed adulterated due to insanitary conditions.

Key violations include: 1. **Inadequate Hazard Analysis and HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The HACCP plan for "Cold Smoked Seafood Products" lacks a critical control point for thawing frozen fish to control pathogen growth. The extended thawing process without time and temperature controls poses a significant pathogen risk. FDA recommends continuous monitoring and recording of time and temperature, maintaining temperatures at or below 40°F, and reviewing records before further processing. 2. **Inadequate Monitoring Procedures (21 CFR 123(c)(4)):** The HACCP plan for "Cold Smoked Fish Products" lacks adequate monitoring procedures/frequencies at the "cold-smoke" critical control point to control bacterial pathogen growth and C. botulinum toxin production. The listed monitoring procedure, "(b)(4)," is insufficient. FDA recommends continuous monitoring and recording of time and temperatures for the entire cold smoke process.

Additionally, FDA analyses of finished cold smoked nova salmon samples (554