FDA EIR - Nestle Healthcare Nutrition Inc. - June 11, 2021

An FDA inspection of Nestle Healthcare Nutrition Inc.'s Eau Claire, WI facility was conducted from June 7 to June 11, 2021. The comprehensive inspection focused on the manufacturing of infant formula and medical foods, specifically aseptic, shelf-stable products. This included a review of the company's compliance with Infant Formula, Medical Foods, Acidified and Low Acid Canned Foods, and Preventive Controls regulations. Although no formal FDA Form 483, Inspectional Observations, was issued, several issues were discussed with management. These included observations of ingredient spills and a torn glove in the warehouse, indicating potential sanitation and GMP concerns. Deficiencies were noted in record-keeping, such as pre-filled ingredient weights on batch sheets and undocumented changes in barrel use. The inspection also identified a lack of cleaning and sanitation records in certain areas, and instances where timeframes for calibrations, filter replacements, and other quality system activities were exceeded. Additionally, the company was reminded that its Clean-In-Place (CIP) software validation and associated records must comply with 21 CFR Part 11 requirements. Management acknowledged these findings and committed to implementing corrective actions. The inspection also involved the collection of infant formula and medical food samples for nutritional and label analysis.