483
Cogentix Medical, Inc.FDA 483 - Cogentix Medical, Inc. - April 14, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
Open in Dashboard
ID · dc28af83-f1d1-4068-b4d7-c8eb3c59f970