Capricor, Inc. – FDA 483, Jul 20, 2026

Capricor Inc. in San Diego, CA, received a Form 483 during an FDA inspection for failing to conduct an investigation in accordance with its Investigational New Drug (IND) plan and protocols. The firm demonstrated significant deficiencies, including not following its investigational plan, blinding plan, project management plan, and auditing standard operating procedures. These failures resulted in issues such as unblinded staff having unauthorized access to clinical study data and delayed finalization of audit reports.