483
Rovi Pharma Industrial Services S.A.Rovi Pharma Industrial Services S.A. – FDA 483, Jan 31, 2025
Record Details
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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ID · ced86b4f-621c-4696-be31-8854a17c3c60
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