FDA EIR - Orthodent Laboratory, Inc. - March 24, 2021

An FDA inspection of Orthodent Laboratory, Inc. was conducted from March 22-24, 2021, as part of the FY21 medical device workplan, adhering to CP 7382.845 for medical device manufacturers. The inspection revealed ten significant observations, primarily concerning the firm's quality system and manufacturing processes for Vivid Aligners (Class II). Major issues identified included the absence of a complete device master record and approved specifications for the aligners, and the lack of validation for the 3D printing process and its operating software. Device history records were found to be incomplete, failing to fully document manufacturing compliance.

Further deficiencies included inadequate supplier evaluation and monitoring, and insufficient identification and documentation of product acceptance status. The corrective and preventive action (CAPA) procedures were deemed inadequate, lacking verification of effectiveness and documented investigations. Controls for nonconforming products and rework processes were also not properly established or documented. Additionally, equipment maintenance and calibration schedules were not adequately maintained, personnel training records were missing, and document control procedures lacked proper approval signatures and dates for internal documents. Management accepted all observations and committed to submitting a written response to the FDA with planned corrections and timelines.