483
Visura Technologies, Inc.Visura Technologies, Inc. – FDA 483, Mar 24, 2026
Record Details
Visura Technologies, Inc. in Minneapolis was inspected by the FDA from March 22-24, 2026. The inspection revealed that the firm failed to adequately document procedures for timely complaint handling. Specifically, five cases alleging malfunction of their transesophageal echocardiogram (TEE) camera assist device were not identified and documented as complaints, leading to potential patient safety concerns.
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ID · decc7d2d-dfd0-4303-a1c3-938d0a2b8983
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