FDA Inspection
Bryan Medical IncBryan Medical Inc – FDA Inspection, Jul 23, 2021
Record Details
This FDA Inspection record concerns Bryan Medical Inc, with an inspection on July 23, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bryan Medical Inc
- Inspection Date
- July 23, 2021
- Product Type
- Devices
View Company Profile
ID · 3325ed4e-f6e7-4912-a697-f0620630cf18
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1147030
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Bryan Medical Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 18, 2026 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 1, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 3, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bryan Medical Inc
- FDA Inspection 1331932 - 2026-08-18
- FDA Inspection 1196995 - 2023-02-01
- FDA Inspection 1069142 - 2018-10-03
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