FDA 483 - Bora Pharmaceuticals Injectables Inc - July 22, 2011

Cangene bioPharma, Inc. in Baltimore, MD, was inspected by the FDA from July 18-22, 2011, and received a Form 483 with four observations. The inspection revealed significant issues related to inadequate equipment cleaning procedures, inappropriate equipment design, failure to follow aseptic processing procedures, and ineffective employee training, indicating a moderate level of non-compliance.