FDA 483 - Brock A. Andersen, M.D. - May 20, 2022

Brock A. Andersen, a clinical investigator in Fruitland, ID, was cited for significant deviations during a human clinical study of an investigational drug. The inspection revealed failures in adhering to the investigational plan, including issues with subject eligibility, study drug storage and administration, and other protocol deviations. Additionally, the firm failed to maintain adequate and accurate case histories and informed consent documents.