FDA 483 - BK Meditech Co., Ltd. - January 10, 2020

An FDA inspection of BK Meditech Co., Ltd., a medical device manufacturer in Yanggam-Myeon, Korea, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for design validation, process controls, labeling activities, complaint handling, and medical device reporting. Additionally, their quality audit procedures were found to be insufficient, indicating systemic issues across multiple critical areas.