FDA 483 - Kat Implants, LLC - September 16, 2022

An FDA inspection of Kat Implants, LLC in Portsmouth, NH, a manufacturer of dental implants, revealed two significant observations. The firm failed to adequately maintain complaint files, including not following its own procedures and lacking proper documentation for investigations and potential FDA reporting. Additionally, device history records were found to be deficient, with missing finished device forms and a lack of implementation for Unique Device Identifier requirements.