483
Guard Medical IncGuard Medical Inc – FDA 483, Dec 19, 2022
Record Details
An FDA inspection of Guard Medical Inc in Miami, FL, a specification developer, identified an issue with their complaint handling procedures. The firm's complaint procedure, SOP-0019, Rev A, was found to be inadequate as it did not ensure timely investigation of complaints generated by the firm. This indicates a deficiency in the established processes for receiving, reviewing, and evaluating complaints.
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ID · 9dae22d1-9441-4dde-af6f-b0aff01b4e81
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