FDA 483 - Celgene Corp., d.b.a. Abraxis BioScience LLC - February 26, 2009

Abraxis Bioscience in Melrose Park, IL, was cited for significant quality control and reporting deficiencies during an FDA inspection. The firm released drug products that failed visual particulate specifications and conducted insufficient investigations into customer complaints regarding foreign particulate matter in distributed Abraxane vials. Additionally, the company failed to submit required NDA-Field Alert Reports for these serious product quality issues.