Biomodeling Solutions drew an FDA warning letter after it failed to provide written responses to nonconformities identified in a Form 483.
An FDA inspection of the dental medical device manufacturer’s facility in Beaverton, Oregon — conducted from Aug. 21 through Sept. 11, 2017 — revealed GMP and medical device reporting nonconformities that the agency considers significant violations.
The GMP violations include a lack of written procedures for design control, CAPA actions, and complaint handling. The firm provided a copy of each of these procedures, but the FDA responded to each one by stating “due to a lack of a written response to this observation after the inspection, we are unable to assess the adequacy of implementation of the procedure.”
The last two GMP violations cited in the warning letter were failure to establish procedures for document control and for employee training. The firm provided an unreviewed and unapproved document to dental laboratories for the manufacturing of its devices.
Biomodeling Solutions was also found to have violated the Medical Device Reporting regulation at the time of the inspection as it had not developed procedures that “provide for timely and effective identification, communication, and evaluations of events that may be subject to MOR requirements,” the FDA said.
The agency also requested a meeting with the firm’s president, Gurdev Dave Singh, to discuss other concerns, including promotional and advertising claims, as well as intended use and device modifications, regarding its Daytime Nighttime Appliance and its mandibular Repositioning Nighttime Appliance devices.