FDA EIR - Bayer Healthcare, LLC - July 11, 2002

An FDA inspection of Conceptus Inc., located in San Carlos, CA, took place from July 8 to July 11, 2002. The audit, conducted by Gerald N. McGirl and Barbara A. Crowl, was a Directed Pre-Market Approval (PMA) Data Audit under regulatory guidance CP 7348.810. The focus was on the company's sponsor and monitoring activities for clinical studies related to the Essure Permanent Birth Control System, specifically data supporting PMA P020014.

The primary issue identified during the inspection, and documented on an FDA-483 form issued to President and CEO Steven R. Bacich, was the failure to report unscheduled visit adverse events in the PMA submission. While monitoring procedures were found to be adequate and more frequent than company SOPs required, this omission was a key observation.

The inspection report suggested a classification of Voluntary Action Indicated (VAI) for Conceptus Inc. and recommended a re-inspection after further assignment from the Center for Devices and Radiological Health (CDRH/OC/DBM). All required inspectional information was provided by the firm, and there were no refusals during the process.