FDA 483 - Bora Pharmaceuticals Injectables Inc - August 27, 2010

An FDA inspection of Cangene bioPharma Inc. in Baltimore, MD, revealed significant deficiencies in quality assurance, aseptic processing, and facility maintenance. The firm failed to thoroughly investigate product discrepancies, maintain adequate visual inspection programs, and ensure proper material segregation and preventative maintenance for critical systems. These issues indicate a lack of robust controls over manufacturing processes and product quality.