# FDA 483 - Med-Dyne, Inc. - January 30, 2023

Source: https://www.keypedia.com/records/483/med-dyne-inc/ddf41cee-d1d0-4209-9712-add9f6337944

> FDA 483 for Med-Dyne, Inc. on January 30, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Med-Dyne, Inc.
- Inspection Date: 2023-01-30
- Product Type: device
- Office Name: Cincinnati District Office
- Summary: Med-Dyne, Inc. in Louisville, KY, was inspected by the FDA from January 23-30, 2023. The inspection revealed a significant deficiency in the firm's Medical Device Reporting (MDR) procedures. Specifically, the company's written procedures lacked an internal system for timely identification and monitoring of events subject to reporting requirements, including externally submitted adverse event reports.

## Related Officers

- [Shannon A. Gregory](https://www.keypedia.com/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.keypedia.com/companies/med-dyne-inc/4137b0f6-2fbd-47e2-91b7-ad00ca650019

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22