Office of Manufacturing and Product Quality

Steven Lynn, Office Director

Michael Smedley, Deputy Office Director
 

Drugs, both prescription and over-the-counter (OTC), must be manufactured in accordance with good manufacturing practice requirements. Conformance with these requirements is determined through inspection and compliance evaluations. FDA pre-approval inspections are an integral part of determining if drug applications can be approved. Manufacturing deficiencies found during a pre-approval inspection would need to be corrected before approval can be granted. If a facility isn't ready for inspection, approval can be delayed. After approval, routine FDA inspections evaluate the state of control of the process and facility, under the Agency’s quality systems inspection program.