FDA 483 - Ordont Orthodontic Laboratories Inc - February 08, 2024

Ordont Orthodontic Laboratories Inc. in Fenton, MO, a medical device manufacturer, was cited for numerous significant quality system deficiencies during an FDA inspection. The firm failed to implement basic quality system requirements, including UDI labeling, GUDID submission, design history files, complaint handling, CAPA, device history records, training, and quality audits. These widespread issues indicate a severe lack of control over their manufacturing processes and product quality for their Invisible SmileSeries orthodontic brackets.