# FDA 483 - Eurofins Lancaster Laboratories, Inc - May 30, 2025

Source: https://www.keypedia.com/records/483/eurofins-lancaster-laboratories-inc/4f724384-c3e2-4b72-bc92-271b07af7534

> FDA 483 for Eurofins Lancaster Laboratories, Inc on May 30, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins Lancaster Laboratories, Inc
- Inspection Date: 2025-05-30
- Product Type: drugs
- Office Name: Detroit District Office
- Summary: Eurofins Lancaster Laboratories, Inc. in Portage, MI, a contract testing laboratory, was cited for significant deficiencies across its quality control and laboratory operations. The inspection revealed issues with inadequate investigations into discrepancies and out-of-specification results, poor data integrity controls for electronic systems, and scientifically unsound test procedures. Additionally, the firm failed to follow established procedures and maintain adequately qualified stability chambers, indicating systemic problems in ensuring drug product quality and purity.

## Related Officers

- [Joseph A. Piechocki](https://www.keypedia.com/people/joseph-a-piechocki/1977a57b-4976-4b01-b8da-66a84b26e803)
- [Joohi Castelvetere](https://www.keypedia.com/people/joohi-castelvetere/2340bef8-5105-4f40-9713-120196b70d82)
- [Shannon L. Maisano](https://www.keypedia.com/people/shannon-l-maisano/2cce259d-0fbe-44ef-b43e-7292da739470)
- [Joseph A. Pieciuch](https://www.keypedia.com/people/joseph-a-pieciuch/75a674b6-2d57-419a-b4aa-626b6c27ab0f)
- [Shannon I. Maizano](https://www.keypedia.com/people/shannon-i-maizano/9dad6842-7ba4-4d6f-a321-e65a7c21bf05)

Company: https://www.keypedia.com/companies/eurofins-lancaster-laboratories-inc/a5676b12-3275-4a99-8f4b-3877e1728255

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