# FDA 483 - Fisiopharma Srl - September 27, 2019

Source: https://www.keypedia.com/records/483/fisiopharma-srl/5643b808-20a9-4631-8308-dfc84478a328

> FDA 483 for Fisiopharma Srl on September 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fisiopharma Srl
- Inspection Date: 2019-09-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Fisiopharma Srl, a sterile drug manufacturer in Palomonte, Italy, was cited for significant deficiencies across its quality systems during an FDA inspection. Observations included inadequate aseptic process validation, insufficient investigation of discrepancies, unvalidated test methods, and deficient contamination control systems. The firm also lacked proper production control procedures, quality control unit adherence, and annual product review processes, indicating a broad failure to ensure drug product quality and purity.

## Related Officers

- [Assuring that quality medicines are available to the American public](https://www.keypedia.com/people/maya-m-davis/4180239e-5b21-4f9c-9ff0-6bbe5222f740)

Company: https://www.keypedia.com/companies/fisiopharma-srl/51c980e4-3287-4bc8-a51d-4fe2c414329c

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1