Inspections and testing
FDA ensures adherence to and authenticity of data submitted in the application. FDA confirms what has been submitted in writing through inspections and testing. The agency assures that the manufacturing facilities are in compliance with current good manufacturing practices and that bioequivalence sites are in compliance with current good clinical practices.
FDA inspections are conducted primarily by the Office of Regulatory Affairs with support from the CDER Office of Compliance. Site inspections are assigned geographically and involve teams of inspectors that are physically present to verify that the sites are in compliance. If the inspector finds an issue of concern with a facility, FDA will not approve that product. Periodically, FDA brings products back to its lab to analyze and determine if products meet criteria.