483
ROVI Pharma Industrial Services S.A.ROVI Pharma Industrial Services S.A. – FDA 483, Apr 22, 2016
Record Details
An FDA inspection of Rovi Contract Manufacturing S.L. in Madrid, Spain, revealed significant deficiencies in aseptic processing and quality control systems. The firm failed to adequately monitor environmental conditions, ensure the efficacy of disinfectants, and investigate unexplained discrepancies such as low production yields for sterile drug products.
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ID · e5a19e77-46a1-4446-a679-44f27b28a9e3
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