FDA 483 - Bayer Healthcare, LLC - January 06, 2011

Conceptus, Inc. in Mountain View, CA, a medical device manufacturer, was cited for significant deficiencies in its quality system. The inspection revealed failures to submit Medical Device Reports (MDRs) for serious injuries and device malfunctions, incomplete risk analysis for its Essure product, and inadequate documentation of corrective and preventive actions. These issues indicate a systemic breakdown in post-market surveillance and quality control processes.