# FDA 483 - L. Perrigo Company - March 19, 2025

Source: https://www.keypedia.com/records/483/l-perrigo-company/111c06bc-5bd7-4f7b-8159-eead3b33f698

> FDA 483 for L. Perrigo Company on March 19, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: L. Perrigo Company
- Inspection Date: 2025-03-19
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: L. Perrigo Company in Allegan, MI, was inspected and cited for multiple significant deficiencies related to data integrity, quality control, and facility maintenance. The inspection revealed issues with computer system controls, the drug product stability program, labeling and packaging material procedures, equipment cleaning validation, and adherence to sanitation protocols. These observations indicate a need for improved procedural adherence and robust quality system implementation.

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## Related Officers

- [Anna M. Spiros](https://www.keypedia.com/people/anna-m-spiros/13e6a69c-d3d5-431c-9895-0df9b86691b7)
- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Elizabeth R. Bloom](https://www.keypedia.com/people/elizabeth-r-bloom/51c7ec4e-97bb-4543-adc3-cf02d335f159)
- [ analyst /Microbiologist ](https://www.keypedia.com/people/ana-maria-a-plapcianu/5f370fbd-8ff9-4fcf-ad57-380201abc7cd)
- [Investigator](https://www.keypedia.com/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)

Company: https://www.keypedia.com/companies/l-perrigo-company/47babd74-e5cb-4ab8-959e-35b9d1157e0b

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03