# FDA 483 - Rovi Pharma Industrial Services S.A. - September 22, 2023

Source: https://www.globalkeysolutions.net/records/483/rovi-pharma-industrial-services-sa/ab532f82-eab3-438d-aa11-e196f4456e70

> FDA 483 for Rovi Pharma Industrial Services S.A. on September 22, 2023. 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: 2023-09-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Rovi Pharma Industrial Services S.a. in San Sebastian De Los Reyes, Madrid, a sterile manufacturer, received a Form 483 with two observations. The inspection revealed significant issues with quality control, specifically regarding the thorough review of unexplained discrepancies and out-of-specification results. Additionally, the firm's procedures for cleaning and maintaining equipment were found to be deficient, leading to potential contamination risks.

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## Related Officers

- [Dorothy P. Kramer](https://www.globalkeysolutions.net/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)
- [Jennifer Lalama](https://www.globalkeysolutions.net/people/jennifer-lalama/5ebc4da1-62ac-4b15-89a8-e18b0606e0ff)

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