FDA 483 - Kerry Inc. - February 21, 2019

An FDA inspection of Kerry Inc. in Fort Worth, TX, a seafood manufacturer, revealed significant deficiencies in its HACCP plan. The firm's plan lacked adequate verification procedures for critical control points, failed to identify Clostridium botulinum as a reasonably likely food safety hazard for certain products, and included an insufficient corrective action plan that did not address regaining control of operations after deviations.