# FDA 483 - Rovi Pharma Industrial Services S.A. - June 20, 2022

Source: https://www.globalkeysolutions.net/records/483/rovi-pharma-industrial-services-sa/9f24b402-1690-4d61-afe1-2377b4185e5a

> FDA 483 for Rovi Pharma Industrial Services S.A. on June 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rovi Pharma Industrial Services S.A.
- Inspection Date: 2022-06-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Rovi Pharma Industrial Services S.A., a sterile drug manufacturer in San Sebastian De Los Reyes, Spain, was inspected by the FDA from June 6-20, 2022. The inspection revealed significant deficiencies in quality control, including a failure to investigate numerous out-of-specification and out-of-trend results, inadequate aseptic processing controls, and poorly designed equipment. The firm's Quality Unit was found to not be fully following its responsibilities and procedures, indicating a systemic breakdown in quality assurance for sterile drug products.

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## Related Officers

- [Arsen Karapetyan](https://www.globalkeysolutions.net/people/arsen-karapetyan/4000d909-277b-4533-992f-4e3627c8ce40)

Company: https://www.globalkeysolutions.net/companies/rovi-pharma-industrial-services-sa/947a0616-87f8-4886-a6c2-278c5e678192

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