Gauthier Biomedical, Inc. – FDA 483, Dec 21, 2021

Gauthier Biomedical, Inc., a medical device manufacturer in Grafton, WI, received a Form FDA-483 with five observations, three of which were repeat observations from a previous inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, complaint handling, MDR event file documentation, process validation, and supplier control. These issues indicate a systemic failure to address quality problems and ensure product conformity.