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

Source: https://www.keypedia.com/records/483/patheon-italia-spa/d55baa61-9317-4214-9cf7-a28d38cf62f5

> 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: Office of Medical Device and Radiological Health Operations
- Summary: Thermo Fisher Scientific (Patheon Italia S.p.A.) in Ferentino, Italy, was cited for significant deficiencies across its drug product manufacturing operations. The inspection revealed inadequate Quality Unit oversight, failures in process controls for drug product quality, and critical issues with aseptic processing and environmental monitoring. The findings indicate a systemic lack of assurance regarding product sterility, purity, and overall quality.

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## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4