# FDA 483 - Olon S.p.A. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/olon-spa/bf1c3ae0-5de7-4c9a-9f3e-a14f2184ac8a

> FDA 483 for Olon S.p.A. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olon S.p.A.
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Olon S.p.A in Dorno, Italy, from May 21-23, 2018, identified a significant issue regarding record-keeping. The firm failed to maintain adequate records for equipment use, cleaning, and sanitization, which prevented the evaluation of potential cross-contamination risks for multi-use equipment involved in API processing. This deficiency indicates a lack of control over manufacturing processes and raises concerns about product quality and safety.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)

Company: https://www.globalkeysolutions.net/companies/olon-spa/7e0ac35e-0f38-43f3-8415-015a3d5c0248

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