FDA 483 - Capricor, Inc.

Capricor, Inc. in San Diego, CA, a drug substance and drug product manufacturer, was cited for multiple deficiencies during an FDA inspection from May 27-30, 2025. Observations included inadequate qualification of equipment, failure to follow written procedures for quality management and documentation, and a lack of quality agreements with external facilities. Additionally, the facility's quality control unit lacked written procedures, and equipment was not maintained in a good state of repair.