483
C.P.M. Contract Pharma GmbH & Co. KGC.P.M. Contract Pharma GmbH & Co. KG – FDA 483, Jul 5, 2019
Record Details
C.P.M. Contract Pharma GmbH & Co. KG was cited for significant deficiencies in their quality control systems during an FDA inspection. Observations included inadequate computer system controls for HPLC data integrity, deficient laboratory records lacking verification of electronic source data, and insufficient complaint handling procedures. Additionally, the firm failed to thoroughly review and timely close deviations related to unexplained discrepancies.
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