Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
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Talk to a SpecialistTalk to a SpecialistDr. Angela D. Ritter was cited for violations of federal regulations governing the conduct of clinical investigations at her practice in Gainesville, Georgia, involving her management of expanded access protocols and investigational drug studies. The FDA inspection conducted in August 2023 found that she failed to adhere to the requirements for expanded access uses under 21 CFR 312.305(c) and did not comply with sponsor-investigator and clinical investigator responsibilities outlined in 21 CFR 312 Subpart D. The violations were identified through the FDA's Bioresearch Monitoring Program, which evaluates whether human subject rights, safety, and welfare are adequately protected in clinical research.