FDA EIR - Gerber Products Company - July 14, 2017

An FDA inspection of Gerber Products Corp. (dba: Nestle Nutrition - Gateway), a powdered infant formula manufacturer in Eau Claire, WI, occurred from July 10-14, 2017. The inspection, guided by the Infant Formula and Domestic Food Safety compliance programs, focused on the manufacture of Gerber Good Start Soy infant formula. The previous inspection in July 2016 resulted in a "Voluntary Action Indicated" classification, citing inadequate controls for two-person verification of ingredient measurements, potential cross-contamination between wastewater and infant formula water systems, and incomplete equipment cleaning/sanitizing records. Other concerns included apparent insect activity and employees reviewing their own work.

During the current inspection, no formal FDA-483 observations were issued. However, three items were discussed with management for improvement: the absence of time indications on dryer Clean-In-Place records, the presence of drips on the warehouse floor, and a general need for better cleanliness, with powder observed on equipment surfaces in various production areas. Management was receptive and committed to implementing corrections. Specifically, they agreed to document time checks for CIP records by the end of July, remind employees about spill cleanup diligence, and reinforce pre-production cleaning protocols. Two samples of Gerber Good Start Soy infant formula were collected for nutritional and microbiological analysis.