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Ce laboratoire allemand qui dispose de deux sites en Inde a été mis en demeure par l'agence américaine notamment sur les écarts suivants : 1.     Your firm failed to prepare batch production and control records for each batch of drug product that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch (21 CFR 211.188(b)).   On August 28, 2014, FDA investigators identified instances of non-contemporaneous documentation of batch production activities. Two uncontrolled Excel spreadsheets were used to record discrepancies and certain in-process drug quality data . This data was initially missing in the batch manufacturing record.  Your firm later entered this data into batch records and backdated them . 2.     Your firm failed to maintain adequate written records of major equipment maintenance (21 CFR 211.182).   On August 25, 2...

Ce laboratoire indien connu a reçu une mise en demeure sévère de la US FDA dont voici les écarts les plus significatifs en terme de "Data Integrity" : 1.     Failure to maintain complete data derived from all laboratory tests conducted to ensure compliance with established specifications and standards.   Your laboratory records did not contain all raw data generated during each test for API batches manufactured at your firm. The investigator found that batch samples were routinely re-tested following failing or atypical results until acceptable results were obtained, and that failing or atypical results were not investigated or included in the official laboratory control records.    During the inspection, the presence of an uncontrolled “Custom QC laboratory” (CQC) was discovered by our inspection team. The existence of this laboratory was previously unknown to FDA. Your QC Associate Director acknowledged that t...