Catalent Pharma Solutions, LLC – FDA EIR, Aug 28, 2019

An FDA Level 1 Quality System Inspection (QSIT) was conducted at Catalent Pharma Solutions, LLC in Saint Petersburg, FL, from August 26-28, 2019. The inspection evaluated the firm's compliance as a medical device and drug contract manufacturer, focusing on their Corrective and Preventive Actions (CAPA) and Production & Process Control subsystems, particularly concerning the gelatin encapsulation process. The inspection identified two primary deficiencies, which were detailed in an FDA Form 483. Firstly, the company's procedures for managing nonconforming products were found to be insufficiently defined and implemented. For example, when out-of-specification fill weights occurred, the procedure mandated only re-testing without requiring an investigation into the cause of the initial failure. Furthermore, records for encapsulation machine downtime did not adequately demonstrate that operators performed necessary troubleshooting to identify problem causes before restarting production. Secondly, the gelatin encapsulation process itself was deemed to have incomplete validation. Catalent had not properly identified critical process parameters or sources of variation during their qualification efforts. Instead of monitoring these crucial process elements, the firm relied primarily on testing product samples. The inspector noted that the company's validation report incorrectly categorized product attributes as critical process parameters and failed to recognize a potentially critical process temperature parameter. The FDA emphasized that robust process validation necessitates characterizing the process to identify and control critical sources of variation, ensuring consistent product quality without solely depending on finished product testing. Catalent Pharma Solutions, LLC received an FDA Form 483 outlining these observations. The company committed to implementing voluntary corrections and providing a written response within fifteen business days.