FDA 483 - Bora Pharmaceuticals Injectables Inc - August 10, 2023

Cangene BioPharma, LLC in Baltimore, MD, a drug product manufacturer, was inspected from July 31 to August 10, 2023, and received a Form FDA 483 with four observations. The observations highlight significant deficiencies in contamination control, quality unit procedures, aseptic process validation, and equipment qualification, indicating a lack of robust controls for sterile drug product manufacturing. These issues collectively suggest a moderate to severe risk to product quality and patient safety.