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

Source: https://www.keypedia.com/records/483/patheon-italia-spa/6b1e02e0-7afb-4e86-a960-1a179cf029b1

> FDA 483 for Patheon Italia S.p.A. on November 18, 2022. 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: 2022-11-18
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Patheon Italia S.p.A., Monza Site, a drug product manufacturer, was conducted from November 10 to November 18, 2022, resulting in an FDA Form 483. The report highlighted significant violations across several areas critical to drug manufacturing compliance. Main issues included failures in aseptic processing, where procedures designed to prevent microbiological contamination were not adequately established or followed, such as operators blocking 'first air' to sterile components and making direct contact with non-sterile gloves.

Environmental monitoring in aseptic areas was also found deficient due to an unvalidated hold time for monitoring plates. The firm lacked adequate controls for electronic data acquisition systems, with unvalidated software, shared login credentials, and insufficient validation for data backup. Investigations into deviations were deemed inadequate, failing to identify root causes or implement sustainable corrective actions, evidenced by recurring environmental excursions and analytical test failures.

Furthermore, cleaning and sanitization programs were criticized for ineffective procedures, unscientific acceptance limits in cleaning validation, and inadequate disinfectant efficacy studies. Critical clean utilities were not fully qualified, and a UV-Visible Spectrophotometer in the QC laboratory lacked full calibration for its intended use. Patheon Italia S.p.A. is required to respond to these observations by implementing comprehensive corrective and preventive actions to ensure regulatory compliance.

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## Related Officers

- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [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/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64