FDA EIR - Nestle Healthcare Nutrition Inc. - September 13, 2019

An FDA inspection of Nestle Healthcare Nutrition Inc. in Eau Claire, WI, was conducted from September 9-13, 2019. The inspection focused on the manufacturing of infant formula and medical foods, utilizing compliance programs for Infant Formula, Medical Foods, and Domestic Acidified and Low Acid Canned Foods, alongside cGMP provisions (21 CFR Part 117). While no official FDA Form 483 (Inspectional Observations) was issued, several verbal objections and recommendations were discussed. Key issues included operators failing to record visual and destructive container integrity checks concurrently with the operation and the unauthorized use of uncontrolled log books for batch information. Concerns were also raised regarding incomplete batch records, specifically the omission of minimum water flow rate for a retort, and inconsistent recording of initial temperatures for retorted products. Additionally, fading ink on retort recording charts hindered legibility, and container examination records lacked reference to hermetic seal integrity. Management acknowledged these concerns, initiating some immediate corrective actions, such as revising the procedure for retort chart stickers, and promised to consider further improvements for other noted issues.