# FDA 483 - Patheon Italia S.p.A. - November 18, 2022

Source: https://www.keypedia.com/records/483/patheon-italia-spa/6c026c16-362b-42d2-8eec-e7bdc8a9f447

> FDA 483 for Patheon Italia S.p.A. on November 18, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Patheon Italia S.p.A.
- Inspection Date: 2022-11-18
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Patheon Italia S.p.A. in Monza, Italy, revealed significant deficiencies in aseptic processing, environmental monitoring, and data integrity. The firm failed to establish and follow procedures to prevent microbiological contamination of sterile drug products, lacked adequate controls for electronic data systems, and did not thoroughly investigate deviations or implement effective corrective actions. These issues indicate a high risk of product contamination and compromised data reliability.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/patheon-italia-spa/6b333cf8-6726-49e5-98e0-fa970f1473f0)
- [483 - 2023-05-26](https://www.keypedia.com/records/483/patheon-italia-spa/f259b7b4-ddc0-4844-9cb5-7251a521313e)
- [483 - 2023-05-26](https://www.keypedia.com/records/483/patheon-italia-spa/79cf157f-fd82-4b03-8b1c-6b688732e007)
- [483 - 2023-09-05](https://www.keypedia.com/records/483/patheon-italia-spa/ab7e638d-4556-4e47-8f30-029b81bb0b76)
- [483 - 2023-09-29](https://www.keypedia.com/records/483/patheon-italia-spa/697016d3-1468-40c9-aab9-50d983f73540)

## Related Officers

- [Melissa Reig](https://www.keypedia.com/people/melissa-reig/93329e0c-aae6-4691-ad4f-a554212febbe)
- [Zhong Li, Ph.D., Sr. Pharmaceutical Quality Assessor](https://www.keypedia.com/people/zhong-li-phd-sr-pharmaceutical-quality-assessor/cdc177bb-92f6-4d53-ba84-6e878c68917a)
- [Melissa Ray, Ph.D., Microbiologist](https://www.keypedia.com/people/melissa-ray-phd-microbiologist/f737d5d7-f769-4db6-bc2c-b38cd8430f54)

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

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