FDA 483 - Capricor, Inc. - May 30, 2025

An FDA inspection conducted at Capricor, Inc. from May 27-30, 2025, identified several significant issues indicating non-compliance with current Good Manufacturing Practices (CGMP). The firm, a manufacturer of drug substances and drug products located in San Diego, California, received a Form FDA 483 detailing five key observations.A primary concern was the inadequate qualification of manufacturing processes, where dynamic conditions used in testing did not accurately reflect actual production environments. Furthermore, the inspection revealed a systemic failure to adhere to the company The FDA also noted the absence of essential quality agreements with multiple contract facilities providing critical services like product release and testing. Additionally, the quality control unit lacked written procedures for fundamental activities such as receiving and evaluating product complaints and handling returned products. Finally, equipment was observed not to be maintained in a state of good repair, with rust identified in a manufacturing suite. Capricor, Inc. is now required to address these observations by implementing comprehensive corrective and preventive actions to ensure regulatory compliance.