FDA 483 - Gerber Products Company dba Nestle Nutrition - April 22, 2022

During an inspection conducted from March 5 to April 14, 2022, the FDA issued a Form 483 to Gerber Products Company dba Nestle Nutrition, an infant formula manufacturer located in Eau Claire, WI. The inspection revealed significant concerns regarding process controls, personnel hygiene, and sanitation documentation, which are critical for preventing product adulteration under the Federal Food, Drug and Cosmetic Act. A primary violation was the failure to establish adequate process controls to prevent microbial contamination. This included observed recurring water leaks in critical drying areas, which were not properly documented. Environmental samples collected by both the FDA and the company confirmed the presence of Cronobacter sakazakii in multiple hygiene zones of the powder infant formula production plant, specifically within the dryer areas while product was being manufactured. Additionally, a product sample of Gerber Good Start Gentle Milk Based Infant Formula powder tested positive for the same pathogen. Further observations noted inadequate personnel hygiene practices, where an employee handling infant formula scoops failed to change gloves after touching non-contact surfaces, equipment, or even wiping their nose. Lastly, deficiencies in cleaning and sanitizing records were identified, including a lack of specific equipment identification in cleaning logs and incomplete procedural instructions for sanitation processes. The company is expected to implement prompt corrective actions to address these serious observations and ensure compliance with regulatory standards.