# FDA 483 - Patheon Italia S.p.A - February 18, 2025

Source: https://www.globalkeysolutions.net/records/483/patheon-italia-spa/9f320c1a-0092-422b-b21e-bcd9e816d61b

> FDA 483 for Patheon Italia S.p.A on February 18, 2025. 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: 2025-02-18
- Product Type: Drugs
- Office Name: Office of Inspections and Investigations
- Summary: Thermo Fisher Scientific (Patheon Italia S.p.A.) located in Ferentino, Italy, underwent an FDA inspection from February 10 to 18, 2025. The inspection revealed significant compliance issues primarily related to the Quality Unit's (QU) oversight and process controls. Key observations included inadequate documentation and investigation of discrepancies, such as the failure to open deviation records for unqualified standards and exceeding reinspection limits. Additionally, there was insufficient verification of microbial sampling within expiry dates and inadequate oversight of aseptic process simulations.

The inspection also highlighted failures in establishing process controls to ensure drug products meet specified identity, strength, quality, and purity. Notably, the stoppering process lacked adequate validation and control, with no engineering runs performed to establish critical process parameters. Furthermore, the packaging system for sterilization was not evaluated for risk impact on product quality, and inappropriate storage conditions for drug substances were observed.

The FDA's observations indicate a need for Thermo Fisher Scientific to enhance its QU oversight, establish robust process controls, and ensure compliance with regulatory standards to prevent product quality issues. The company is expected to address these deficiencies through corrective actions and submit responses to the FDA detailing their plans to rectify these issues.

## Related Documents

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- [483 - 2025-02-10](https://www.globalkeysolutions.net/records/483/patheon-italia-spa/bb7e80c7-776a-45a2-b0b1-705ff194f21a)

## Related Officers

- [Pharmaceutical Scientist](https://www.globalkeysolutions.net/people/ekaterina-allen/760a7817-8e5b-45f9-82ee-db6ca139a92e)
- [Senior Regulatory Specialist](https://www.globalkeysolutions.net/people/wayne-e-seifert/e92e1f10-c61e-4b08-9156-25907e5e2942)

Company: https://www.globalkeysolutions.net/companies/patheon-italia-spa/31dc9e92-7b25-4af0-82b4-c57b3efafbcf

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8