Perrigo Wisconsin, LLC

Warning LetterOpen

Bart D. Shrode Vice President of Quality Operations Perrigo Wisconsin, LLC 5023 Venture Dr. Eau Claire , WI 54703 United States Bart.Shrode@perrigo.comFEI 3003520374Issued Aug 30, 2023HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3003520374.

Violations2

Issue DateAug 30, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Perrigo Wisconsin, LLC
Location: Bart D. Shrode Vice President of Quality Operations Perrigo Wisconsin, LLC 5023 Venture Dr. Eau Claire , WI 54703 United States Bart.Shrode@perrigo.com
FEI Number: 3003520374
Country: United States
Issue Date: August 30, 2023
Issuing Office: HUMAN AND ANIMAL FOOD WEST I COMPLIANCE BRANCH (HAFW1-CB)
Product Type: Drugs
Status: Open

Summary

Perrigo Wisconsin, LLC was cited for significant violations of infant formula Current Good Manufacturing Practice (CGMP) requirements and quality control procedures under 21 C.F.R. Part 106 at its Gateway facility in Eau Claire, Wisconsin, following an FDA inspection from March through April 2023. The facility, recently acquired from Nestle in November 2022 along with the Good Start infant formula brand rights, was found to have manufactured adulterated infant formula in violation of the Federal Food, Drug, and Cosmetic Act. The company submitted corrective actions in May 2023, but FDA determined these actions were insufficient to address the serious compliance failures discovered during the inspection.

Perrigo Wisconsin, LLC FDA Warning Letter, August 30, 2023