FDA 483 - ARCA biopharma, Inc. - March 09, 2009

ARCA biopharma, Inc. in Broomfield, CO, was inspected as a Sponsor-Monitor and received a Form 483 with two observations. The inspection revealed significant issues with recordkeeping, specifically regarding investigational drug disposition and the retention of essential study documentation. These findings indicate a moderate level of non-compliance with regulatory requirements for clinical trial oversight and record management.