FDA EIR - Gerber Products Company dba Nestle Nutrition - July 17, 2015

An FDA inspection of Gerber Products Corp. (dba: Nestle Nutrition - Gateway) in Eau Claire, WI, took place from July 13-17, 2015. The inspection's scope included batch record review, on-site sanitation, and quality assurance procedures, with a focus on verifying compliance with new Infant Formula regulations and discussing new FSMA requirements. While no formal FDA-483 observations were issued, several issues were identified and discussed with facility management. These included incomplete records lacking lot numbers for infant formula production aggregates in equipment cleaning logs, discovery of an oil-like substance in the Almix tipping room, sticky floors in a processing area, and inconsistent recording of values across various records. Furthermore, a specific batch record review revealed that homogenizer pressure readings were documented in psi, contrary to the operating range specified in bars. Management expressed receptiveness and committed to implementing the necessary corrections. The report also highlighted the firm's robust environmental sampling and allergen control programs, noting no deficiencies in finished product or environmental testing results from August 2014 to June 2015. The facility adheres to regulatory frameworks such as 21 CFR 107.100 for nutrient testing requirements.