FDA WARNING_LETTER - Bacalao Brothers, Inc. - July 26, 2011

On October 20, 2011, the FDA issued a Warning Letter to Bacalao Brothers, Inc. dba New England Fish Market, following an inspection from July 25-26, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

The primary issue is that the firm's pasteurized crab meat is considered adulterated because it was prepared, packed, or held under insanitary conditions, potentially rendering it injurious to health.

Specific violations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(c)(4)):** * The revised HACCP plan for pasteurized crab meat (dated 8/1/2011) improperly relies on Time Temperature Indicators (TTIs) for monitoring *Clostridium botulinum* growth at receiving and storage. FDA recommends TTIs only for the end-user, and they must be affixed and activated by the primary processor. * Monitoring storage temperatures "2 times per day" is insufficient, as it allows for 12-hour lapses and does not cover weekends/holidays. FDA recommends continuous 24/7 monitoring with daily checks. * The plan mentions "crab is