FDA 483 - Spaulding Clinical Research - November 16, 2023

An FDA inspection of Spaulding Clinical Research in West Bend, WI, a BIMO Clinical Investigator, identified a significant issue regarding informed consent documents. The inspection revealed that informed consent forms for a specific study lacked descriptions of reasonably foreseeable risks or discomforts, did not accurately list the number of blood draws, and omitted details about IV catheter placement, indicating a serious deficiency in subject protection.