# FDA 483 - Patheon Italia S.p.A. - September 05, 2023

Source: https://www.globalkeysolutions.net/records/483/patheon-italia-spa/ab7e638d-4556-4e47-8f30-029b81bb0b76

> FDA 483 for Patheon Italia S.p.A. on September 05, 2023. 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: 2023-09-05
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Patheon Italia S.p.A. in Monza, Italy, a drug product manufacturer, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate preventative maintenance on a sterile fill line, insufficient procedures for material allocation during performance qualification, and aseptic process simulations that did not accurately reflect production. Additionally, the cleaning and disinfection of the RABS aseptic processing area were found to be inadequate.

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## Related Officers

- [Richard Ledwidge](https://www.globalkeysolutions.net/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.globalkeysolutions.net/companies/patheon-italia-spa/eb421078-fb58-4c48-a8ae-f1c1befb8145

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