# FDA 483 - Perrigo Wisconsin, LLC - November 29, 2023

Source: https://www.globalkeysolutions.net/records/483/perrigo-wisconsin-llc/8ac4a650-548d-4819-859b-ffcece40c97b

> FDA 483 for Perrigo Wisconsin, LLC on November 29, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Perrigo Wisconsin, LLC
- Inspection Date: 2023-11-29
- Product Type: drugs
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Perrigo Wisconsin, LLC, an infant formula manufacturer in Eau Claire, WI, revealed significant deficiencies in process controls, sanitation, and personnel qualifications. The firm repeatedly failed to prevent environmental contamination, particularly with Cronobacter species, and exhibited poor cleaning practices and inadequate employee training. These issues, some of which are repeat observations, indicate a high risk of product adulteration.

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- [WARNING_LETTER - 2023-04-26](https://www.globalkeysolutions.net/records/warning_letter/perrigo-wisconsin-llc/1c112226-98a7-443a-8a27-19afbdb853d4)

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/krista-k-petersen/cd35bbdd-17b6-4d77-bdc8-ce1d99cbc877)
- [Investigator](https://www.globalkeysolutions.net/people/amy-l-mcintyre/713bba22-598e-4367-9b92-65848875b342)
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Company: https://www.globalkeysolutions.net/companies/perrigo-wisconsin-llc/1f673ad3-dfd3-491e-bf90-6f080085f12e

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d
