# FDA 483 - Patheon Italia S.p.A - February 10, 2025

Source: https://www.globalkeysolutions.net/records/483/patheon-italia-spa/bb7e80c7-776a-45a2-b0b1-705ff194f21a

> FDA 483 for Patheon Italia S.p.A on February 10, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Italia S.p.A
- Inspection Date: 2025-02-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Thermo Fisher Scientific (Patheon Italia S.p.A.) in Ferentino, Italy, revealed significant deficiencies in quality unit oversight, process controls, and aseptic manufacturing practices. The firm failed to adequately manage investigations, validate critical processes, ensure sterility, and maintain effective visual inspection and environmental monitoring programs. These issues collectively indicate a lack of robust quality systems necessary to assure drug product quality and purity.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/patheon-italia-spa/cdea28c7-73b2-4efa-bdbe-3ccc10b086ba)

## Related Officers

- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [Pharmaceutical Scientist](https://www.globalkeysolutions.net/people/ekaterina-allen/760a7817-8e5b-45f9-82ee-db6ca139a92e)

Company: https://www.globalkeysolutions.net/companies/patheon-italia-spa/31dc9e92-7b25-4af0-82b4-c57b3efafbcf

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd