The Food and Drug Administration (FDA or the Agency) is denying a request for a hearing submitted by Richard M. Fleming (Fleming) and is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Fleming for 10 years from providing services in any capacity to a person that has an approved or pending drug product application.
FDA bases this order on a finding that Fleming was convicted of two felonies under Federal law that involved fraud. Additionally, Fleming has demonstrated a pattern of conduct sufficient to find that there is reason to believe that he may violate requirements under the FD&C Act relating to drug products. In determining the appropriateness and period of Fleming's debarment, FDA considered the relevant factors listed in the FD&C Act. Fleming failed to file with the Agency information and analyses sufficient to create a basis for a hearing concerning this action.
DATES:
The order is applicable September 28, 2018.