FDA WARNING_LETTER - Kelley's Katch - February 09, 2012

On February 7-9, 2012, the FDA inspected Kelley's Katch in Savannah, Tennessee, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, 21 CFR Part 123. As a result, the firm's paddlefish roe (caviar) and paddlefish products are considered adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions. A FORM FDA 483, Inspectional Observations, was issued. Key violations included the HACCP plan's failure to list adequate monitoring procedures for critical limits, specifically for salt content in caviar, and the firm's failure to implement monitoring procedures for temperature control of received salted roe. Additionally, monitoring records for cooler temperatures lacked dates, times, and signatures/initials. The firm's verification procedures were deficient, not including calibration of instruments or review of monitoring, corrective action, and calibration records. Furthermore, critical control point monitoring records for Clostridium botulinum toxin formation were not reviewed within one week. The FDA warns of potential further actions, including product seizure or injunction, and the assessment of re-inspection fees. Kelley's Katch must respond in writing within 15 working days, detailing specific corrective actions and providing supporting documentation.