# FDA 483 - Olon SPA - June 05, 2017

Source: https://www.keypedia.com/records/483/olon-spa/124650ba-59a9-4d69-bd29-9be0064798f9

> FDA 483 for Olon SPA on June 05, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Olon SPA
- Inspection Date: 2017-06-05
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: An FDA inspection of Capua BioServices SpA, an API manufacturer, revealed significant deficiencies in the design and monitoring of its water distribution system. The firm failed to adequately prevent contamination of drug substances due to issues with routine monitoring, sampling, testing, and identification of microbial growth. These findings indicate a lack of control over a critical utility used in drug substance production.

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/samantha-j-bradley/ba45f64f-07a9-4933-833f-b9b339c57783)
- [Zachary A. Bogorad](https://www.keypedia.com/people/zachary-a-bogorad/ae582dcd-f893-44a5-98bd-0b55f401577b)

Company: https://www.keypedia.com/companies/olon-spa/7df58e77-f9cb-4929-8d1b-0f9a728b86cf

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4