FDA EIR - Bayer HealthCare LLC - July 01, 2015

An FDA inspection was conducted at Bayer HealthCare LLC, located in Milpitas, CA, from April 27, 2015, to July 1, 2015. This inspection was specifically a sponsor inspection related to a clinical study involving the company's device, Essure. The review was carried out under FACTS Assignment # 11468333, a directed assignment by the CDRH Division of Bioresearch Monitoring, indicating a focus on bioresearch monitoring aspects of the regulatory framework. Investigators examined records for studies, specifically searching for information pertaining to complaints from study subjects enrolled between 2001 and 2003, and also collected design control information as requested by CDRH. Notably, the inspection concluded with no issues observed by the investigator. Consequently, the recommended classification for this inspection was "No Action Indicated" (NAI), meaning no regulatory violations were identified and no further actions were required from the firm based on this review. This outcome suggests the firm was found to be in compliance with the aspects covered during the inspection.