FDA 483 - Precision Align LLC - July 20, 2023

Precision Align LLC, a manufacturer of orthodontic plastic brackets in Fort Lauderdale, FL, was cited for multiple deficiencies in its quality system during an FDA inspection. The observations primarily concern inadequate procedures and documentation for device history records, medical device reporting, supplier evaluation, incoming product acceptance, equipment maintenance, and personnel training. These issues indicate a significant lack of control over critical manufacturing and quality processes.