# FDA 483 - Cogentix Medical, Inc. - April 14, 2022

Source: https://www.keypedia.com/records/483/cogentix-medical-inc/dc28af83-f1d1-4068-b4d7-c8eb3c59f970

> FDA 483 for Cogentix Medical, Inc. on April 14, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cogentix Medical, Inc.
- Inspection Date: 2022-04-14
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/kwong-p-lee/f4778925-1fad-4988-9e39-86482896c4fa)

Company: https://www.keypedia.com/companies/cogentix-medical-inc/f390823b-956f-4ec5-adcc-32c9dc279ec6

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961