FDA 483 - Amtai Medical Equipment, INC - February 28, 2022

Amtai Medical Equipment, INC, a medical device manufacturer in Raleigh, NC, was inspected by the FDA from February 22-28, 2022. The inspection revealed significant deficiencies in their quality system, including inadequate procedures for environmental control, equipment maintenance, labeling activities, and document control. These observations indicate a lack of established and adequately implemented quality system processes.