# FDA 483 - Patheon Italia S.p.A. - September 29, 2023

Source: https://www.globalkeysolutions.net/records/483/patheon-italia-spa/697016d3-1468-40c9-aab9-50d983f73540

> FDA 483 for Patheon Italia S.p.A. on September 29, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Patheon Italia S.p.A.
- Inspection Date: 2023-09-29
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: An FDA inspection of Patheon Italia S.p.A., a biological drug manufacturer in Monza, Italy, identified a significant issue with adherence to established warehousing procedures. The firm failed to follow its written SOP for tracking the storage and movement of materials, leading to discrepancies between inventory records and physical stock in dispensing and storage areas. This indicates a breakdown in material control and record-keeping practices.

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## Related Officers

- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)
- [Scott T. Ballard](https://www.globalkeysolutions.net/people/scott-t-ballard/09b2ae9a-3b30-45bd-bac1-437365e938da)

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

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