FDA 483 - Daniel M. Gruener, M.D. - January 21, 2020

An FDA inspection of Daniel M. Gruener, M.D. in Saint Louis, MO, identified a significant deficiency related to the maintenance of informed consent documents. The firm failed to prepare or maintain adequate and accurate case histories, specifically by not retaining original informed consent forms for multiple subjects participating in a clinical study. This finding highlights concerns regarding recordkeeping and the protection of human subjects in clinical research.