# FDA 483 - Patheon Italia S.p.A - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/patheon-italia-spa/cdea28c7-73b2-4efa-bdbe-3ccc10b086ba

> FDA 483 for Patheon Italia S.p.A on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Italia S.p.A
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: Patheon Italia S.p.A., a sterile drug product manufacturer in Ferentino, Italy, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate deviation investigations, issues with equipment and process validation, and insufficient laboratory controls. These findings indicate a lack of robust quality systems to ensure the sterility and quality of drug products.

## Related Documents

- [483 - 2025-02-10](https://www.globalkeysolutions.net/records/483/patheon-italia-spa/bb7e80c7-776a-45a2-b0b1-705ff194f21a)

## Related Officers

- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)
- [Marion Michaelis](https://www.globalkeysolutions.net/people/marion-michaelis/4fa99c28-0925-4618-b5c7-fc610573284b)

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

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321