Oregon Device Firm Draws FDA Warning

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.”