FDA 483 - Kleen-Pak Foods, Inc - April 12, 2019

Kleen-Pak Foods, Inc. in Milwaukee, WI, a vegetable repacker, was cited for multiple deficiencies during an FDA inspection. The firm's hazard analysis failed to identify significant biological hazards for spinach, and its process controls for washing spinach were not adequately validated. Additionally, the company lacked proper corrective action procedures for process control deviations and failed to implement written sanitation monitoring procedures.