FDA 483 - Bora Pharmaceuticals Injectables Inc - August 01, 2012

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.