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

Source: https://www.keypedia.com/records/483/patheon-italia-spa/c31ddd71-7332-465a-b0d1-3bc236e2d357

> 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: Center for Drug Evaluation and Research
- Summary: An FDA inspection of Thermo Fisher Scientific (Patheon Italia S.p.A.) in Ferentino, Italy, conducted from February 10–18, 2025, identified significant deficiencies in drug product manufacturing. The inspection focused on the facility"s adherence to sterile processing and quality management standards. The primary violations involved inadequate Quality Unit oversight. The facility failed to document investigations into batch discrepancies, including exceedances in validated filling times and the use of out-of-tolerance instruments. Furthermore, the Quality Unit lacked control over visual inspection qualification sets, which were stored in an unsecured state and poorly maintained. Significant risks regarding microbiological contamination were noted. Aseptic process simulations did not accurately reflect commercial manufacturing, and operators were qualified without performing critical routine interventions. Inspectors also observed poor aseptic techniques, such as operators touching sterile surfaces with non-sterile equipment. The visual inspection program for sterile products was deemed insufficient. Qualification kits were not properly blinded, and the firm failed to scientifically justify inspection times or detection probabilities for particulates. Additionally, environmental monitoring and cleaning protocols were inadequate, as disinfectant efficacy studies did not utilize site-specific isolates or account for the entire shelf-life of cleaning agents. Thermo Fisher Scientific is required to address these observations by submitting a detailed response to the FDA outlining their corrective and preventive action plans. This response must include specific timelines for resolving the identified lapses in process validation, quality oversight, and contamination control.

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## Related Officers

- [Pharmaceutical Scientist](https://www.keypedia.com/people/ekaterina-allen/760a7817-8e5b-45f9-82ee-db6ca139a92e)
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Company: https://www.keypedia.com/companies/patheon-italia-spa/31dc9e92-7b25-4af0-82b4-c57b3efafbcf

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c