FDA EIR - Bayer Healthcare, LLC - July 11, 2008

An FDA inspection of Conceptus Inc., a manufacturer of permanent sterilization devices, was conducted from July 9 to July 11, 2008. The inspection, classified as a routine Level 1 Quality System Inspection Technique (QSIT) assignment, focused on the company's compliance with established quality system regulations, specifically reviewing Corrective and Preventive Actions (CAPA) and Design Controls for their Essure model ESS305 device. The inspection concluded with favorable findings. Investigators observed no issues or deficiencies during their review of the company's operations. Consequently, no FDA-483 Inspectional Observations were issued to Conceptus Inc. This outcome indicates that the company was found to be operating in compliance with applicable regulatory requirements at the time of the inspection. The inspection was classified as "No Action Indicated" (NAI), signifying that no further regulatory actions or corrective measures were required from the company based on this inspection. This positive outcome aligns with a previous inspection in 2005, which also resulted in no observations.