FDA 483 - Boehringer Ingelheim Pharma GmbH & Co. KG - May 01, 2018
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An FDA inspection of Boehringer Ingelheim Pharma GmbH & Co. KG, a finished drug and API manufacturer, revealed significant deficiencies in record-keeping, process validation, and quality control. Observations included incomplete inventory reconciliation, lack of process validation for solvent recovery, inadequate deviation investigations, and insufficient documentation of critical manufacturing steps and line clearances. These issues indicate a need for improved adherence to good manufacturing practices.
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