FDA EIR - Bayer Healthcare, LLC - June 26, 2013

An FDA Level 1 Quality System Inspection Technique (QSIT) inspection was conducted at Conceptus, Inc., located in Mountain View, CA, from May 30, 2013, to June 26, 2013. Conceptus, Inc. manufactures the Essure permanent contraceptive implant coils. The inspection, a routine follow-up, specifically reviewed the firm's Complaint Handling, Corrective and Preventive Actions (CAPA), and Design Control systems. Notably, previous observations from an inspection conducted in late 2010 to early 2011, which had highlighted issues with Medical Device Report (MDR) reporting, CAPA documentation, and Design Risk Assessment, were verified as corrected during this current visit. During the 2013 inspection, investigators found no new issues or violations. Consequently, no FDA Form 483, which lists observations of objectionable conditions, was issued. The inspection's classification was "No Action Indicated" (NAI), indicating satisfactory compliance with regulatory requirements. The inspection also noted correspondence between Conceptus, Inc. and the Center for Devices and Radiological Health (CDRH) clarifying MDR reporting requirements. Specifically, complaints regarding implant coils found in the abdominal cavity outside the fallopian tubes, or cases of uterine pregnancy, were not required to be reported as MDRs unless they caused pain necessitating surgical removal or other specific conditions. This demonstrates regulatory engagement and clarification on reporting protocols. Overall, the inspection concluded with no adverse findings, affirming the company's adherence to quality system regulations at the time.