Perrigo Wisconsin, LLC – FDA EIR, Aug 19, 2021

An FDA inspection of Gerber Product Company dba Nestle Nutrition, an infant formula manufacturer in Eau Claire, WI, occurred from August 10-19, 2021. Guided by the Infant Formula Program and Preventive Controls regulations, the inspection found no formal observations warranting an FDA Form 483. However, several issues were verbally discussed. These included observations of powder build-up on equipment, a loose bolt on the floor, dirty scoops, and improper use of gloves as equipment caps, all of which were corrected during the inspection. Other concerns involved missing documentation for pre/post CIP records, undocumented corrective actions for inspection failures or exceeded CIP limits, delayed equipment calibrations, and instances of employees handling non-food contact surfaces before can ends. Most critically, an in-process powder sample tested positive for Cronobacter. This resulted in the quarantine of a specific batch of Nestle Nan 1 Pro Infant Formula Powder, highlighting a significant product safety issue requiring comprehensive corrective action, despite no formal regulatory citation being issued at the time of inspection close.