FDA 483 - Catalent Indiana, LLC - September 01, 2022

An FDA inspection of Catalent Indiana, LLC in Bloomington, IN, revealed significant deficiencies in the manufacturing of sterile human drug and biologic products. The firm failed to thoroughly investigate discrepancies, adequately handle complaints, ensure proper equipment design and validation, and maintain robust aseptic processing controls. These issues indicate a systemic lack of adherence to quality standards and pose potential risks to product quality and sterility.