St. James Smokehouse (Scotland) Ltd. – FDA Warning Letter, Jun 8, 2012

On September 12, 2012, the FDA issued a Warning Letter to St. James Smokehouse Inc. following an inspection from May 13 to June 8, 2012, at their Miami, FL facility. 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 vacuum-packed cold smoked salmon products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) due to insanitary conditions. Key violations included:

1. **Failure to Implement Monitoring Procedures:** The firm did not follow its HACCP plan's monitoring procedures for "temperature data logger during transit" at the "Receive Delivery" critical control point, with multiple cold smoked salmon shipments lacking temperature records. Similarly, "temperature data logger" monitoring at "Transfer to Chilled Storage" was not followed. 2. **Inadequate Verification Procedures:** The firm failed to perform "Weekly calibration of temperature probes" at the "Receive Delivery" critical control point, with calibration records showing probes last calibrated on March 28, 2012. 3. **Inadequate Critical Limits:** The HACCP plan's critical limits of "Internal temperature of delivery no greater than 38