FDA EIR - Bayer HealthCare LLC - July 01, 2015

An FDA inspection of Bayer HealthCare LLC, located in Milpitas, CA, was conducted from April 27, 2015, to July 1, 2015. This was a sponsor inspection focused on a clinical study involving the company's device, Essure. The inspection was a directed assignment by the FDA's Center for Devices and Radiological Health (CDRH) Division of Bioresearch Monitoring, aligning with regulatory oversight for medical device clinical trials. The scope of the inspection involved reviewing records for studies, specifically searching for information related to complaints from study subjects enrolled between 2001 and 2003. Additionally, design control information was collected as requested by CDRH. Despite the detailed review of these areas, the investigator observed no issues or deficiencies during the inspection. Consequently, the recommended classification for this inspection was "No Action Indicated" (NAI). This classification signifies that the firm was found to be in compliance with applicable regulations, and no regulatory actions were required as a result of this comprehensive evaluation.