FDA WARNING_LETTER - robert bugatto enterprises, inc., - July 29, 2011

On November 25, 2011, the FDA issued a Warning Letter to Robert Bugatto Enterprises, Inc., dba The Tides Wharf, following an inspection from July 25-29, 2011, at their Bodega Bay, CA facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123), rendering their canned, refrigerated, reduced oxygen packaged Dungeness crab, and hot and cold smoked fish adulterated under 21 U.S.C. § 342(a)(4).

Key violations include: 1. **Lack of HACCP Plan:** No HACCP plan for canned, refrigerated, reduced oxygen packaged Dungeness crab to control pathogenic growth and toxin formation, including *Clostridium botulinum*. 2. **Inadequate HACCP Monitoring Procedures:** * **Hot Smoked Fish:** HACCP plan lacked adequate monitoring for histamine control at receiving (primary and secondary processor), storage (recommended continuous monitoring), and thawing/butchering (incorrect temperature monitoring). Brining monitoring procedures did not correspond to critical limits for brine strength and soak time. * **Cold Smoked Aquacultured Salmon in Vacuum Packaging:** Receiving monitoring for pathogen growth was inadequate (lacked time/temperature details). Storage monitoring was insufficient (recommended continuous monitoring). Brining monitoring frequency (quarter