FDA Inspection
dBMEDx, IncdBMEDx, Inc – FDA Inspection, Mar 27, 2025
Record Details
This FDA Inspection record concerns dBMEDx, Inc, with an inspection on March 27, 2025, issued by the Denver District Office, covering medical devices & rad health.
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ID · 1d483c79-271f-4921-9fd3-3ba9fe7349ba
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1265088
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of dBMEDx, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 7, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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