FDA: Reporting Allegations of Regulatory Misconduct
02 February 2018
|The FDA encourages people submitting allegations to include supporting information and contact information in case additional information is needed for the FDA to understand the allegation and act on the report; however you can choose to submit a report anonymously. The FDA will not share your identity or contact information with anyone outside the FDA unless required to do so by law, regulation, or court order.||FDA
US Food and Drug Administration
What kinds of allegations can be reported?
Allegations of regulatory misconduct may include failure to register and list a medical device, marketing uncleared or unapproved products, failure to follow quality system requirements, or misleading promotion. The table below provides some examples of the kind of allegations the FDA has received:
Examples of allegations
|Allegations of Regulatory Misconduct Branch
Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
WO Bldg. 66 RM 3523
10903 New Hampshire Ave
Silver Spring, MD 20993
Find NEWS and PUBLICATIONS here according to your interests or use the search box.