FDA 483 - Bora Pharmaceuticals Injectables Inc - August 26, 2014

An FDA inspection of Cangene bioPharma, Inc. dba Emergent BioSolutions in Baltimore, MD, revealed significant deficiencies in manufacturing process controls and raw material testing. The firm failed to adequately validate the scale-up of a contract drug product's formulation and filling process, neglecting to review critical analytical data. Additionally, the company accepted supplier analyses for raw materials without performing identity testing or verifying supplier reliability, raising concerns about product quality and safety.