FDA 483 - Catalent Pharma Solutions LLC - September 28, 2020

An FDA inspection of Catalent Pharma Solutions LLC in Morrisville, NC, a combination drug/device manufacturer, revealed significant deficiencies in design control procedures. The firm failed to adequately establish procedures and plans for design validation, verification, input, output, and overall design and development for its Albuterol Sulfate Inhalation Aerosol combination device. These findings indicate a lack of fundamental controls in the product development lifecycle.