FDA EIR - Catalent Indiana, LLC - August 03, 2018

An FDA routine GMP surveillance inspection of Catalent Indiana, LLC, a contract manufacturer of human pharmaceutical products and medical devices, was conducted from July 31 to August 3, 2018. This inspection, carried out under CPGM 7345.848 for Biological Drug Products, focused on the company’s quality and laboratory control systems. While no FDA Form 483 was issued, the inspection identified several significant discussion items requiring corrective action. Key observations included: inconsistencies in following the bioburden testing procedure, a lack of robust electronic recordkeeping for environmental monitoring data where original entries could be modified without traceability, and unrestricted capabilities to alter time and date stamps on critical laboratory equipment like pH meters and analytical balances. Furthermore, issues were noted within the aseptic process simulation program, specifically regarding inadequate justification for intervention frequencies during media fills, and production intervention frequencies not being fully supported by these studies. The firm also lacked written procedures for qualifying personnel performing visual inspections of media-filled units and had insufficient acceptance criteria for growth promotion of media. Finally, a sanitization procedure in a manufacturing area was observed not to be followed correctly. Catalent management committed to assessing these findings to implement necessary corrections, with some actions already underway, such as opening a Corrective and Preventive Action (CAPA) for media fill issues and planning data integrity remediation by the end of 2019.