FDA 483 - Advance Medical Designs, Inc. - June 30, 2023

Advance Medical Designs, Inc. in Marietta, GA, was inspected regarding its manufacturing of Class II Sterile Ultrasound Gels. The inspection revealed significant deficiencies in design control procedures, design history file documentation, device master record maintenance, and supplier qualification processes. These issues indicate a lack of adherence to medical device quality system regulations.