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

Source: https://www.keypedia.com/records/483/patheon-italia-spa/46879db9-db9a-4ec7-8c47-669937147549

> 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: Baltimore District Office
- Summary: The FDA conducted an inspection of Thermo Fisher Scientific (Patheon Italia S.p.A.), a drug product manufacturer located in Ferentino, Italy, from February 10 to 18, 2025. The inspection revealed several significant issues primarily related to the Quality Unit's (QU) oversight and process controls.

Key violations included inadequate documentation and investigation of discrepancies and deviations. For instance, the firm failed to open deviation records for the use of unqualified standards and procedures during reinspection processes and did not investigate the root causes of exceeded validated filling times. Additionally, there were lapses in equipment calibration and microbial sample testing within defined expiry dates.

The inspection also highlighted deficiencies in the control and storage of qualification sets for personnel performing visual inspections. These sets were found in unsecured locations and were not adequately monitored for defects. Furthermore, the QU did not independently verify non-integral vials rejected during aseptic process simulations, relying solely on production operators' assessments.

The regulatory framework requires that drug manufacturers ensure the identity, strength, quality, and purity of their products. The FDA observed that Thermo Fisher Scientific failed to establish adequate process controls, particularly in the validation and control of the stoppering process for bulk products.

The FDA expects the company to address these issues by implementing corrective actions, including improving documentation practices, enhancing QU oversight, and establishing robust process controls to ensure compliance with regulatory standards.

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## Related Officers

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

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa