The Santa Barbara Smokehouse, Inc. – FDA Warning Letter, May 4, 2012

The FDA issued a Warning Letter to The Santa Barbara Smokehouse, Inc. following a May 2012 inspection, citing serious violations of seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR Part 123) and Current Good Manufacturing Practice (GMP) regulations (21 CFR Part 110). This renders their ready-to-eat vacuum packed smoked salmon products adulterated under Section 402(a)(4) of the Act. Significant HACCP deficiencies include the "Smoked Salmon" plan's failure to list food safety hazards (parasites, undeclared allergens) and the "Thawing" critical control point. Critical limits for product core temperature and fish receiving were inadequate for controlling pathogenic growth. The firm also failed to implement monitoring procedures for water phase salt and had an inappropriate corrective action plan for "Fish Receiving." Sanitation monitoring was insufficient, with issues like lack of backflow prevention, incorrect sanitizer use, cross-contamination risks, and poor employee hygiene, violating 21 CFR 123.11(b) and 21 CFR Part 110. Additionally, the firm failed to perform an affirmative step for imported "fresh" salmon to ensure HACCP compliance (21 CFR § 123.12 (a)(2)(ii)). The FDA found the firm's May 2012 response partially inadequate. The company must provide a written response within fifteen working days, detailing specific corrections and supporting documentation. Failure to comply may result in refusal of imported products, detention, seizure, injunction, and reinspection fees.