FDA WARNING_LETTER - Bubbas Fish House - March 01, 2013

An FDA inspection of Bubba's Fish House, located at 737 Easter Day Road, Grand Rivers, KY, on February 27 and March 1, 2013, revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice regulation (21 CFR Part 110). The firm's paddlefish roe was deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions, specifically the failure to control Clostridium botulinum during unrefrigerated processing. Although the firm submitted a corrective action letter on March 11, 2013, it was deemed inadequate. Key violations included the failure to list critical limits in the HACCP plan for Clostridium botulinum toxin formation at the unrefrigerated processing critical control point and for pathogen growth at receiving (21 CFR 123.6(c)(3)). Additionally, the HACCP plan's monitoring procedures for the processing critical control point were inadequate to control C. botulinum toxin formation (21 CFR 123.6(c)(4)), and the corrective action plan for storage was inappropriate as it did not consider unrefrigerated product time for safety (21 CFR 123.7(b)). The FDA warned of potential further actions, including product seizure or injunction, and the assessment of reinspection fees. The firm was required to respond within fifteen working days outlining specific corrections and providing supporting documentation.