Kenex (Electro-Medical) Ltd. – FDA 483, Mar 14, 2024

Kenex (Electro-Medical) Ltd., a medical device manufacturer in Harlow, United Kingdom, was inspected by the FDA from March 11-14, 2024. The inspection revealed significant deficiencies across multiple quality system areas, primarily concerning the lack of established procedures for design control, complaint handling, process control, finished device acceptance, labeling, and Medical Device Reporting (MDR) for their Mobile Detector Holder product. These findings indicate a broad failure to implement essential quality system requirements for medical device manufacturing.