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

Source: https://www.keypedia.com/records/483/rovi-pharma-industrial-services-sa/131a35ad-146b-489b-8125-30ca4fc47f94

> 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: Center for Biologics Evaluation and Research
- Summary: The FDA conducted an inspection of Rovi Pharma Industrial Services S.A., a biological drug product manufacturer, from January 23 to January 31, 2025. This resulted in a Form FDA 483, citing significant deviations from Good Manufacturing Practices. The inspection highlighted four primary issues requiring the company's immediate attention.

First, the firm failed to thoroughly investigate unexplained discrepancies. Specifically, approximately 13 Restricted Access Barrier System (RABS) glove integrity failures occurred since August 2023, yet batches processed using these potentially compromised gloves were released without adequate investigation or impact assessment.

Second, procedures intended to prevent microbiological contamination of sterile drug products were found to be insufficient. Reusable tools stored within RABS units were not consistently disinfected before use, and operators were observed utilizing them without prior sanitization, posing a risk to product sterility.

Third, the accuracy of data inputs and outputs, particularly from the RABS glove integrity testing equipment, was not properly controlled or verified. Raw data was often not confirmed, and in one instance, a critical test result was not documented and was overlooked during supervisory review. The company also struggled to provide all generated test results for released batches.

Finally, batch production and control records were deficient, lacking the essential identification numbers of major equipment, such as the RABS glove integrity testing devices, used during aseptic filling. Rovi Pharma Industrial Services S.A. must address these observations promptly to ensure full compliance with regulatory standards and uphold product quality and safety.

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