FDA EIR - Perrigo Wisconsin, LLC - August 15, 2018

An FDA inspection of Gerber Products Corp. (dba: Nestle Nutrition - Gateway) in Eau Claire, WI, was conducted from July 16 to August 15, 2018. The inspection focused on the processing of powdered infant formula, including ingredient handling, thermal processing, and packaging, guided by FDA's Infant Formula Program and Domestic Food Safety guidelines (CP 7321.006 and CP 7303.803).

While no formal FDA Form 483 (Inspectional Observations) was issued, several verbal objections were raised and discussed with management. Key issues included the failure to change two out of three critical zone filters for approximately 19 months, stemming from an error in the preventive maintenance scheduling system. Additionally, discrepancies were found in sanitation cleaning logs, such as identical completion times for multiple tasks, lack of documented investigations for deviations, and improper record-keeping by employees. An unlabeled Clean-In-Place (CIP) preparation tank was also identified, contravening identification requirements under 21 CFR 117 regulations.

In response, management promptly initiated corrective actions. The filter maintenance schedule was revised immediately to ensure individual tracking, with all affected filters slated for replacement during the September 2018 plant shutdown. For the sanitation log issues, the company committed to reviewing annotation methods and conducting refresher training for employees, also seeking FDA guidance on revised documentation. The unlabeled tank was corrected on-site during the inspection. Management expressed receptiveness and committed to addressing all identified areas for improvement.