FDA 483 - Dentonics, Inc - September 19, 2024

Dentonics, Inc. in Monroe, NC, a manufacturer of dental devices, received a Form FDA 483 with six observations during an inspection from September 16-19, 2024. The observations primarily concern significant deficiencies in quality system procedures, including inadequate process validation, missing design history files, and poorly maintained device master and history records. Several observations were repeats from previous inspections, indicating persistent issues with quality system implementation and control.