FDA 483 - Aju Pharm Co., Ltd. - January 23, 2025

Aju Pharm Co., Ltd., a medical device manufacturer in Seongnam-Si, Gyeonggi, Korea, was cited for numerous quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for design validation, corrective and preventive actions, complaint handling, supplier evaluation, production processes, process controls, and sampling plans. Additionally, written Medical Device Report (MDR) procedures were found to be inadequate, indicating significant issues across multiple critical areas of their quality management system.