483
Bora Pharmaceuticals Injectables IncFDA 483 - Bora Pharmaceuticals Injectables Inc - August 01, 2012
Record Details
An FDA inspection of Cangene bioPharma, Inc. in Baltimore, MD, a drug manufacturer, revealed a significant observation regarding deviations from written production and process control procedures. The firm failed to adequately justify additional mixing times, proceed with filling despite out-of-specification protein concentration results without root cause, and use drug substance with black specks without proper risk assessment documentation. These issues indicate a lack of documented justification for critical manufacturing decisions and product release.
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ID · 7cd75684-6adc-40ee-8339-d3d53b9fca82