Catalent Indiana, LLC – FDA 483, May 1, 2018

During inspections conducted between April 23 and May 1, 2018, the U.S. Food and Drug Administration (FDA) issued an FDA Form 483 to Cook Pharmica LLC, a drug substance manufacturing facility located in Bloomington, Indiana. The inspection identified several significant observations concerning the facility's adherence to manufacturing quality standards. Key issues included an unacceptably high and increasing trend of mold recoveries in classified manufacturing rooms (ISO-7 and ISO-8), indicating potential environmental control deficiencies. Inspectors also found instances where written procedures designed to prevent drug substance contamination were not consistently followed, as evidenced by a bioburden excursion linked to improperly set up equipment. Furthermore, the FDA noted a lack of adequate quality oversight in the review of manufacturing records and procedures, leading to situations where high bioburden levels did not automatically trigger necessary investigations. The document also highlighted deficiencies in corrective and preventive action systems, specifically that implemented actions failed to prevent the recurrence of deviations, such as the use of defective filters. Lastly, the inspection revealed serious data integrity concerns, as controls on the firm’s HPLC and GC computer systems were insufficient to prevent unauthorized changes to data, allowing for the alteration of real-time records without administrative authorization. Cook Pharmica LLC is required to respond to these observations with comprehensive corrective actions to address the identified issues and ensure compliance with regulatory expectations.