FDA 483 - Stephen J. Monteith, MD - June 09, 2025

An FDA inspection of Stephen J. Monteith, MD, a clinical investigator site in Seattle, WA, revealed significant deficiencies in clinical trial conduct. The firm failed to properly report Serious Adverse Events to the sponsor according to the protocol and maintained inaccurate and incomplete subject case histories. These findings include documents with invalid dates and unreported adverse events and concomitant medications, indicating a lack of adherence to investigational plan requirements and good clinical practice.