483
Cogentix Medical, Inc.Cogentix Medical, Inc. – FDA 483, Apr 14, 2022
Record Details
Cogentix Medical, Inc. in Orangeburg, NY, was inspected by the FDA from April 12-14, 2022. The inspection revealed that device history records were not adequately maintained. Specifically, documentation from a contracted repair facility lacked proper headers and identification of personnel who performed repair and maintenance work.
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ID · dc28af83-f1d1-4068-b4d7-c8eb3c59f970
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