FDA 483 - Bayer HealthCare LLC - June 30, 2015

An FDA inspection of Bayer Healthcare LLC's Milpitas, CA facility was conducted from April 27 to June 30, 2015. The inspection focused on the company's sponsor operations for clinical research related to the Essure system for permanent birth control, a medical device. This review was initiated by a CDRH Bioresearch Monitoring assignment, conducted under Compliance Program 7348.810, which pertains to Sponsors, Contract Research Organizations, and Monitors. The inspection covered various aspects including clinical operations, investigator selection, adverse event reporting, data handling, and record retention, also incorporating a review of historical clinical study files from the acquired company, Conceptus, Inc. Notably, the inspection found no significant observations of current sponsor activities and no site-specific objectionable conditions. Consequently, the FDA investigators did not issue an FDA Form 483. The report highlighted that some reviewed data originated from older studies using an obsoleted clinical management system. As no violations were identified, no specific corrective actions were formally required during this inspection.