DRAXIS Manufacturing Facilities Pass Extensive FDA Inspection

DRAXIS Manufacturing Facilities Pass Extensive FDA Inspection
May 30 2007
Industry Canada:Pharmaceuticals
DRAXIS Health Inc. (Mississagua) has received notification from the US Food and Drug Administration (FDA) that the company's manufacturing operations in Montreal, Quebec continue to maintain their classification as acceptable facilities following an extensive inspection by the FDA in January 2007 of all six production and quality systems at DRAXIS Pharma, the contract manufacturing division of DRAXIS Health. The successful inspection was conducted primarily with regard to two additional products manufactured on behalf of clients in the DRAXIS Pharma sterile lyophilization (freeze-drying) production facility. There were no Form 483 Inspectional Observations issued during the FDA evaluation of DRAXIS systems. The FDA inspections also involved evaluations in DRAXIS Health's radiopharmaceutical business unit, DRAXIMAGE. The inspections form part of each client's FDA regulatory application to authorize DRAXIS to manufacture products for distribution in the United States. http://www.draxis.com