Blake G. Simmons, OD – FDA 483, Jul 27, 2026

An FDA inspection of Blake G. Simmons, OD, a clinical investigator in Colorado Springs, revealed significant deficiencies in the conduct of a clinical investigation. Observations included failures to adhere to the signed statement of investigator regarding subject eligibility and investigational drug product use, issues with obtaining legally effective informed consent, and inadequate maintenance of accurate case histories and study data. These findings indicate a lack of control over critical aspects of clinical trial conduct and data integrity.