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

Source: https://www.globalkeysolutions.net/records/483/patheon-italia-spa/6b333cf8-6726-49e5-98e0-fa970f1473f0

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Patheon Italia S.p.A. in Monza, Italy, underwent an FDA inspection from August 30 to September 3, 2021, focusing on drug product manufacturing. The inspection revealed significant deficiencies in aseptic techniques and procedures for preventing microbiological contamination during sterile drug product filling operations. These issues indicate a failure to maintain adequate control over sterile manufacturing processes.

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## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/michael-r-shanks/dd24952b-4309-451e-afe8-f68892cd7bac)

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