FDA EIR - Corcept Therapeutics Incorporated - October 19, 2020

An FDA inspection of Corcept Therapeutics Incorporated was conducted from October 14 to October 19, 2020, at their Menlo Park, CA facility. The inspection was a focused review of the company's postmarket surveillance and reporting procedures for its only approved drug product, Korlym (mifepristone), which is used for controlling hyperglycemia in patients with Cushing's Syndrome. The regulatory framework for this inspection specifically targeted compliance with Postmarket Adverse Drug Event (PADE) reporting requirements under NDA 202107. The FDA investigator reviewed the company's established procedures for PADE evaluation and reporting, including product complaint files and randomly selected complaint forms. The inspection also covered the firm's pharmacovigilance subcontractors and electronic data systems used for safety and complaint management. Additionally, two postmarket clinical studies related to Korlym were examined. Crucially, the inspection concluded without any observations of objectionable conditions. The FDA investigator did not issue an FDA Form 483 (Inspectional Observations), indicating full compliance with the inspected areas. Consequently, no specific violations or required actions were noted during this inspection, reflecting an effective adverse drug event reporting system at Corcept Therapeutics.