FDA 483 - Kentec Medical, Inc - July 30, 2018

Kerrtec Medical, Inc. in Irvine, CA, was inspected regarding its medical device manufacturing operations. The inspection revealed significant deficiencies across its quality system, particularly in corrective and preventive actions, purchasing controls, medical device reporting, and various aspects of design control including verification, validation, and review. These issues indicate a systemic failure to adequately establish and implement procedures crucial for ensuring product quality and safety.