FDA 483 - Catalent Massachusetts, LLC - November 30, 2021

An FDA inspection conducted at Catalent Massachusetts, LLC from November 8 to November 30, 2021, revealed several significant observations related to good manufacturing practices. The primary issues included deficiencies in the routine calibration and requalification of essential manufacturing equipment, such as cold storage units and sterilizers. Specifically, requalification processes did not adequately represent temperature distribution or include necessary heat penetration studies. Furthermore, the company failed to assess the impact of overdue equipment assessments and requalifications, citing COVID-19 staffing limitations. The inspection also identified inadequate procedures for preventing microbial contamination, noting that operators were allowed to conduct multiple component tests without supervisor notification or investigation into failures. Additionally, Catalent Massachusetts, LLC did not sufficiently verify the reliability of component suppliers’ analyses; for example, capsules were not fully tested against all appropriate specifications during requalification, despite the firm's own plans requiring such testing. Finally, cleaning and maintenance procedures for GMP manufacturing areas were found to be deficient, exhibiting inconsistencies in protocols for environmental monitoring excursions and lacking essential details like cleaning agent contact times. These observations necessitate a comprehensive response from Catalent Massachusetts, LLC outlining corrective and preventive actions to ensure compliance with regulatory standards.