FDA 483 - Medicore Co., Ltd. - November 09, 2023

During an inspection conducted from November 6-9, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA-483 to Medicore Co., Ltd., a Class II device manufacturer located in Seongnam, Gyeonggi, Korea. The inspection revealed five significant observations regarding the company's quality system, indicating a need for corrective actions to comply with regulatory requirements for medical devices.

Key issues included a failure to adequately review and investigate customer complaints for their Max Pulse device, with several records lacking documented investigations or justifications. The firm also demonstrated inadequate procedures for controlling non-conforming products, specifically in investigating recurring issues and initiating corrective and preventive actions (CAPA) without obtaining evidence of supplier corrections or implementing heightened incoming evaluations. Furthermore, Medicore Co., Ltd. lacked adequate procedures for incoming inspection controls for critical components, simply receiving them into inventory without evaluation. Deficiencies were also noted in device history records, which often omitted primary labels and labeling, and in training procedures, where documentation for standard operating procedures (SOPs) and work instructions was absent, and recent procedure updates were not covered in training.

Medicore Co., Ltd. is responsible for conducting internal audits to identify and rectify all quality system violations in response to these observations.