# FDA 483 - Rovi Pharma Industrial Services S.A. - June 02, 2023

Source: https://www.globalkeysolutions.net/records/483/rovi-pharma-industrial-services-sa/37319618-4734-4669-b75a-c512d866a3eb

> FDA 483 for Rovi Pharma Industrial Services S.A. on June 02, 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: 2023-06-02
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Rovi Pharma Industrial Services S.A. in Alcala de Henares, Spain, revealed deficiencies in equipment cleaning, facility segregation, and reserve sample examination. The firm failed to adequately clean equipment between batches and ensure proper separation of manufacturing operations. Additionally, procedures for visually examining reserve samples for deterioration were found to be insufficient.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/saied-a-asbagh/215bfa90-995f-4310-baf3-cd9d37639b7b)

Company: https://www.globalkeysolutions.net/companies/rovi-pharma-industrial-services-sa/92dc52fe-a8d7-4a23-bc34-be68892d8866

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