483
410 Medical, Inc.410 Medical, Inc. – FDA 483, Mar 12, 2020
Record Details
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.
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ID · a5dabccd-3ab3-4e0a-873d-219b566df398
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