# FDA 483 - Olon S.p.A. - September 13, 2019

Source: https://www.globalkeysolutions.net/records/483/olon-spa/4f9316f1-e641-494a-807a-a14454926a65

> FDA 483 for Olon S.p.A. on September 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olon S.p.A.
- Inspection Date: 2019-09-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Olon S.p.A. in Rodano, Milan, Italy, was inspected by the FDA from September 9-13, 2019. The inspection revealed a significant issue regarding data integrity, specifically the firm's failure to ensure the accuracy and integrity of electronic data backed up from computerized laboratory systems. This indicates a serious lapse in data management practices for API and intermediate drug product analysis.

## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

Company: https://www.globalkeysolutions.net/companies/olon-spa/9dd52d78-ca3e-4520-bf08-4077a46010a8

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