# FDA 483 - Patheon Italia S.p.A. - May 26, 2023

Source: https://www.globalkeysolutions.net/records/483/patheon-italia-spa/79cf157f-fd82-4b03-8b1c-6b688732e007

> FDA 483 for Patheon Italia S.p.A. on May 26, 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: 2023-05-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Patheon Italia S.p.A. in Monza, Italy, a sterile drug manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate environmental monitoring in aseptic processing, scientifically unjustified media fill designs for sterile products, and improperly qualified equipment. Additionally, the firm's warehouse lacked scientifically-driven temperature mapping studies for drug product storage.

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## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/brandy-n-lepage/41e679e3-cc2a-4361-bf89-26acbd7deaf8)
- [Mindy M. Chou](https://www.globalkeysolutions.net/people/mindy-m-chou/3d0e74bf-ad6b-48b5-8b72-cbb29e9c9ce5)

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

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1