C.P.M. Contract Pharma GmbH & Co. KGJuly 5, 2019

FDA 483 - C.P.M. Contract Pharma GmbH & Co. KG - July 05, 2019

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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.

Company: C.P.M. Contract Pharma GmbH & Co. KG
Inspection Date: July 5, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
Person: Anita Narula (Compliance Officer - CDER/OC/OMQ)

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ID · 6fd7946e-91bc-4c43-b31d-dc7b2c589aab