FDA 483 - Perrigo Wisconsin, LLC - July 28, 2016

During an inspection conducted from July 25-28, 2016, at Gerber Products Corp (dba: Nestle Nutrition-Gateway) in Eau Claire, WI, the U.S. Food and Drug Administration (FDA) issued a Form 483, detailing significant observations. The inspection, targeting an infant formula/food manufacturer, identified three primary areas of concern regarding adherence to manufacturing controls and sanitation.Firstly, the company failed to ensure proper verification during ingredient addition. Specifically, records for Probiotics lacked the required second-person check to confirm the correct weight or measure, a critical control point in manufacturing processes.Secondly, a significant sanitation concern was noted regarding a Clean-Out-of-Place (COP) tank. A pipe connection below the flood rim in the washroom lacked adequate backflow prevention, posing a risk of cross-contamination between waste water and systems used for infant formula production. This directly contravenes standards designed to prevent contamination.Lastly, deficiencies were found in record-keeping for equipment cleaning and sanitizing. Documentation for certain Clean-in-Place (CIP) procedures was incomplete, specifically missing the time of operation completion.These observations highlight potential deviations from good manufacturing practices under the Federal Food, Drug, and Cosmetic Act. Gerber Products Corp is required to promptly address these findings by implementing robust corrective actions to ensure the safety and quality of its infant formula products and maintain full regulatory compliance.