FDA Inspection
Med-Dyne, Inc.Med-Dyne, Inc. – FDA Inspection, Nov 1, 2016
Record Details
This FDA Inspection record concerns Med-Dyne, Inc., with an inspection on November 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fc6517d4-a81f-40cd-95ef-f6179200639e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 999363
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Med-Dyne, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2025 | Not classified | Cincinnati District Office | |
| January 30, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 21, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 15, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Med-Dyne, Inc.
- FDA Inspection 1289796 - 2025-11-06
- FDA Inspection 1195952 - 2023-01-30
- FDA Inspection 1091481 - 2019-05-21
- FDA Inspection 728705 - 2011-06-15
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