FDA 483 - restor3d Inc. - May 12, 2023

An FDA inspection of restor3d Inc. in Durham, NC, from May 8-12, 2023, identified significant deficiencies in the firm's quality system. Observations included inadequate procedures for corrective and preventive actions, failure to follow supplier management protocols, and insufficient documentation of employee training. These issues indicate a need for improved adherence to established quality system requirements for this medical device manufacturer.