FDA 483 - HUREV Co., Ltd. - June 02, 2023

During an inspection conducted from May 30 to June 2, 2023, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Hurev Co. Ltd., a medical device manufacturer located in Wonju-Si, Gangwon-Do, Korea. The inspection identified two significant observations related to the company's quality system, indicating areas for improvement in compliance with medical device regulations. The first observation concerned inadequate process validation. Specifically, the sealing process for Baxter Starling electrodes lacked defined actual sealing temperatures and belt speeds, relying solely on machine settings. Furthermore, the validation failed to demonstrate seal integrity or provide justification for its omission as an acceptance criterion. The second observation noted deficiencies in the Device History Record (DHR). For the HeartRode Pre Wired Electrode Model HR-NR15, the DHR did not include a Unique Device Identifier (UDI) label or a reference to its location, which is a critical component for traceability. Hurev Co. Ltd. has committed to addressing both issues within one month. These observations highlight areas where the company's procedures and records require enhancement to ensure product quality and safety.