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

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.