FDA 483 - Janet Thomas, M.D. - November 27, 2017

Janet A. Thomas, M.D., a clinical investigator in Aurora, CO, was cited for significant deficiencies during an FDA inspection related to two clinical studies for Phenylketonuria. The inspection revealed failures in conducting investigations according to the signed statement of investigator, including issues with subject eligibility, diet monitoring, and self-administration training. Additionally, the firm failed to maintain adequate and accurate case histories, specifically regarding the reporting of adverse events and documentation of subject medications, and the informed consent documents lacked descriptions of reasonably foreseeable risks associated with study supplements.