FDA 483 - Bora Pharmaceuticals Injectables Inc - April 09, 2014

Cangene bioPharma, Inc. dba Emergent BioSolutions in Baltimore, MD, was cited for inadequate process performance qualification and validation for its HP Acthar Gel. The inspection revealed a lack of written procedures for production and process controls, specifically concerning batch size increases and associated documentation. This indicates significant deficiencies in ensuring drug product quality and purity.