# FDA 483 - Rovi Pharma Industrial Services S.A. - January 31, 2025

Source: https://www.keypedia.com/records/483/rovi-pharma-industrial-services-sa/ced86b4f-621c-4696-be31-8854a17c3c60

> FDA 483 for Rovi Pharma Industrial Services S.A. on January 31, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Rovi Pharma Industrial Services S.A.
- Inspection Date: 2025-01-31
- Product Type: biologics
- Office Name: Office of Inspections and Investigations
- Summary: Rovi Pharma Industrial Services S.A. in San Sebastian De Los Reyes, Madrid, was cited for significant deficiencies in its manufacturing processes for sterile drug products. Observations included failures to investigate RABS glove integrity failures, inadequate procedures for preventing microbiological contamination, and poor data integrity practices for glove testing results. Additionally, batch records lacked essential equipment identification.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/unnee-ranjan/43f1d07e-4079-4d33-88a9-baf6a5df932c)
- [Investigator](https://www.keypedia.com/people/burnell-m-henry/dece4407-3597-4a58-8756-5abf9db43bbc)

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

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8