FDA 483 - Andrew C Sedillo, MD - May 07, 2025

Mcb Clinical Research Centers Llc, a clinical investigator in Colorado Springs, CO, was inspected and cited for significant deficiencies in its conduct of a clinical study. The inspection revealed failures to maintain adequate and accurate case histories, including issues with source documentation, staff oversight, and record integrity. Additionally, the firm failed to conduct the investigation according to the protocol, specifically regarding adverse event reporting and staff training.