FDA EIR - Intrinsic Therapeutics, Inc. - March 31, 2017

An FDA bioresearch inspection of Intrinsic Therapeutics, Inc. in Woburn, MA, was conducted from March 27 to March 31, 2017. This high-priority inspection, assigned by CDRH's Division of Bioresearch Monitoring and conducted under Compliance Program 7348.810 (Sponsors, Contract Research Organizations, and Monitors), focused on the firm's ongoing medical device clinical study. While no FDA Form 483 (Inspectional Observations) was issued, the inspection identified and discussed several discrepancies with company management. Key issues included Clinical Investigators not providing updated financial disclosure forms in a timely manner, sometimes years after changes occurred. Additionally, at one site, the Statement of Investigator form was signed only after the first subject had already been screened. A single instance of late reporting of a Serious Adverse Event (SAE) to the Data Safety Management Board (DSMB), exceeding the protocol's five-working-day timeframe, was also noted. Management acknowledged these findings and committed to addressing them internally to prevent recurrence. The inspection concluded without formal observations but highlighted areas for improvement in adherence to study protocols and regulatory requirements for financial disclosures and adverse event reporting.