FDA Inspection
Med-Dyne, Inc.Med-Dyne, Inc. – FDA Inspection, Jun 15, 2011
Record Details
This FDA Inspection record concerns Med-Dyne, Inc., with an inspection on June 15, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Med-Dyne, Inc.
- Inspection Date
- June 15, 2011
- Product Type
- Devices
View Company Profile
ID · c9b70e70-e9b4-43f9-8ca4-d86ee9987568
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 728705
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.100(b)Documentation
- 21 CFR 820.22Quality audits - auditor independence
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.30(g)Design validation - documentation
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 |
| November 1, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 999363 - 2016-11-01
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