FDA 483 - 410 Medical, Inc. - March 12, 2020

410 Medical Inc. in Durham, NC, was inspected from March 9-12, 2020, and received a Form 483 with two observations. The inspection revealed deficiencies in the firm's medical device reporting (MDR) procedures, specifically regarding the identification and evaluation of potentially reportable events. Additionally, the firm failed to adequately maintain complaint files, with several found to be missing key information.