FDA 483 - Keller Laboratories - March 17, 2023

National Dentex LLC, dba NDX Keller, a medical device manufacturer in Fenton, MO, was inspected by the FDA from March 13-17, 2023. The inspection revealed significant deficiencies in the maintenance of device master records, specifically regarding UDI labeling, and inadequacies in procedures for device history records, including missing critical manufacturing and approval documentation. These issues indicate a lack of control over essential quality system elements for their anti-snoring medical devices.