Successful FDA Audit
Pillar5 Pharma – Press Release
August 9, 2011
Pillar5 Pharma Successfully Passes FDA Inspection
Pillar5 Pharma Inc. recently received notice that they have successfully passed a cGMP and pre-approval inspection (PAI) for a New Drug Application (NDA) by the U.S. Food and Drug Administration to manufacture a solid dose product on behalf of one of its clients. The acceptable rating was received after full inspection by the FDA of the Quality, Facility and Equipment, Materials, Laboratory, Production, Packaging and Labeling Systems, and a PAI, with no 483 observations.
“I am very pleased that Pillar5’s high quality standards and expertise were reflected in the outcome of this inspection” notes John Carkner, President and CEO of Pillar5. “This is a significant milestone for our client partnership and brings this important product one step closer to market.”
About Pillar5 Pharma:
Pillar5 Pharma Inc. is a private company established in 2009 and based in Arnprior, Ontario. The manufacturing facility was established in 1956 by Pfizer and has a long-standing record of manufacturing quality products for the pharmaceutical industry. Pillar5 Pharma’s “Foundation of Excellence” is state-of-the-art equipment, infrastructure and processes, along with proven expertise in the manufacturing and packaging of oral solid and sterile ophthalmic products. Leveraged with outstanding customer service, we strive to provide solutions that manage our client’s manufacturing complexity.