Catalent Indiana, LLC – FDA 483, May 12, 2023

Catalent Indiana, LLC in Bloomington, IN, was cited for significant deficiencies during an FDA inspection. The observations primarily concern failures to follow or establish written production and process control procedures, inadequate equipment revalidation, and poor maintenance and cleaning of equipment and facilities. These issues indicate a lack of control over aseptic processing and overall facility integrity, posing potential risks to product quality and sterility.