FDA EIR - Perrigo Wisconsin, LLC - July 12, 2019

An FDA inspection of Gerber Products Corp. (dba: Nestle Nutrition - Gateway) in Eau Claire, WI, was conducted from July 8-12, 2019. The inspection, part of the HAFW1 work plan for FY19 and guided by the Infant Formula Program and Current Good Manufacturing Practices, focused on the manufacturing of powdered infant formulas, including batching, drying, and packaging of Gerber Good Start Soy infant formula. While no formal FDA-483 observations were issued, nine items were discussed with management for correction.

Main issues identified included inadequate facility sanitation and equipment maintenance, such as a sifter lid with visible powder residue, dusty metal totes, and a sticky substance on the warehouse floor. Operational concerns involved the improper use of latex gloves on air handling pipe ports, general powder accumulation, and a poorly designed table hindering effective cleaning. Documentation problems were also noted, specifically missing dates/times on cleaning records and a lack of recorded corrective actions for failed inspections or exceeded cleaning limits. Additionally, the practice of having the same employee perform both sanitation monitoring and reviews was highlighted.

Management committed to addressing all identified issues. Required actions include thoroughly cleaning and properly storing equipment, washing contaminated totes, resolving spills, replacing temporary covers with appropriate caps, rectifying powder accumulation, and evaluating the problematic table design. Employee training will be implemented to ensure accurate documentation for cleaning procedures and proper recording of corrective actions. The firm also agreed to review its sanitation monitoring and review procedures to ensure appropriate segregation of duties.