Conceptus Inc. – FDA EIR, Jul 11, 2008

A routine Level 1 Quality System Inspection Technique (QSIT) was conducted by the FDA at Conceptus Inc., a manufacturer of permanent sterilization devices, from July 9 to July 11, 2008. The inspection, carried out by the FDA's Field office, specifically focused on the company's Corrective and Preventive Actions (CAPA) and Design Controls for their Essure model ESS305. This followed a previous routine inspection in September 2005, which similarly resulted in no observations. During the current review, the investigator meticulously examined the relevant processes and documentation. The inspection concluded with a favorable outcome, as the investigator found no issues or deficiencies requiring regulatory action. As a result, an FDA-483 form, which would document observations of non-compliance, was not issued to the company. The inspection was officially classified as "No Action Indicated" (NAI), signifying that Conceptus Inc. was found to be in compliance with applicable regulatory requirements concerning the inspected quality systems. Therefore, no further actions or corrective measures were mandated by the FDA.