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.”
