FDA 483 - Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd. - September 19, 2024

An FDA inspection of Dongguan Aidisy Machinery & Electronic Equipment Co., Ltd. in Dongguan, China, a medical device manufacturer, revealed multiple significant deficiencies in its quality system. The firm failed to establish adequate procedures for design control, complaint handling, finished device acceptance, in-process product control, and labeling activities. Additionally, sampling plans for functional tests were not based on valid statistical rationale, indicating a broad lack of robust quality management practices.