Bayer Healthcare, LLC – FDA EIR, Jul 7, 2003

An FDA inspection of Conceptus Inc., located in San Carlos, CA, was conducted from June 25, 2003, to July 7, 2003. This post-market approval inspection, a Level 2 Quality System Inspection Technique (QSIT) evaluation, focused on four major subsystems of the firm, which manufactures a device for female sterilization. The inspection identified two significant departures from the Quality System Regulation (QSR), a federal regulatory framework governing medical device manufacturing. Firstly, the company failed to record non-conforming raw materials and subassemblies on the Lot History Records, which is crucial for maintaining product quality and traceability. Secondly, Conceptus Inc. was found not to be consistently following its own Standard Operating Procedures (SOPs) for the control of non-conforming products, indicating a lapse in adherence to established quality processes. These findings echo issues from a previous inspection on July 9, 2002, which also noted departures relating to design controls and Corrective and Preventive Actions (CAPA). Firm management has acknowledged the observations from the current inspection and committed to submitting a written response to the agency detailing their corrective actions. This follow-up is considered a routine part of addressing such inspectional findings.