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

The FDA conducted an inspection of Gerber Products Corp. (dba: Nestle Nutrition - Gateway), an infant formula manufacturer in Eau Claire, WI, from July 25-28, 2016. The inspection, guided by Compliance Programs for Infant Formula and Domestic Food Safety (7321.006 and 7303.803), identified several observations requiring corrective action. Key issues documented on an FDA-483, Inspectional Observations, included: (1) Failure to ensure that each raw or in-process ingredient is examined by one person and checked by a second for correct weight or measure, specifically for probiotics (21 CFR 106.50(b)). (2) Presence of backflow or cross-connection between wastewater systems and infant formula manufacturing water systems, noted in a COP tank lacking proper backflow prevention (21 CFR 110.37(b)(5)). (3) Incomplete records for equipment cleaning and sanitizing, which lacked documentation of the operation's completion time (21 CFR 106.100(f)(4)). Additional concerns discussed included apparent crawling insects, employees reviewing their own work, missing detailed corrective actions for out-of-specification water testing, and inadequate plastic scoop specifications. Management expressed receptiveness and committed to implementing corrections. Actions include addressing ingredient verification, installing backflow prevention units, improving cleaning record documentation, evaluating options for independent work review, enhancing water testing corrective action records, and reviewing plastic scoop specifications. The firm is required to provide written responses outlining their corrective actions.