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

An FDA inspection of Catalent Pharma Solutions LLC in Morrisville, NC, revealed significant deficiencies in the firm's design control procedures for their Albuterol Sulfate Inhalation Aerosol, 90 µg combination device. The company failed to adequately establish and maintain plans and procedures for design validation, verification, input, output, and overall design and development activities. These observations indicate a systemic lack of adherence to regulatory requirements for combination product design controls.