FDA EIR - Conceptus Inc. - July 11, 2002

An FDA document details two inspections of Conceptus Inc., a manufacturer of the Essure Permanent Birth Control System. The first inspection, from July 8-11, 2002, was a PMA data audit focusing on the company's sponsor and monitor activities for Essure clinical studies. The main violation was the failure to report unscheduled visit adverse events in the Premarket Approval (PMA) application, resulting in an FDA-483 observation. A "Voluntary Action Indicated" (VAI) classification was suggested, requiring a re-inspection.

The second inspection, from May 30 to June 26, 2013, was a Level 1 Quality System Inspection Technique (QSIT) covering Complaint Handling, Corrective and Preventive Actions (CAPA), and Design Control for the Essure contraceptive implant coils. During this review, observations from a previous 2010-2011 inspection regarding Medical Device Report (MDR) reporting, CAPA, and Design Risk Assessment were verified as corrected. No new issues were observed during the 2013 inspection, and no FDA-483 was issued, leading to a "No Action Indicated" (NAI) classification. The inspection also clarified specific conditions under which certain complaints were not required to be reported as MDRs.