FDA Inspection
dBMEDx, IncdBMEDx, Inc – FDA Inspection, Oct 7, 2016
Record Details
This FDA Inspection record concerns dBMEDx, Inc, with an inspection on October 7, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 685dc4cc-c554-425e-b5de-e74fbc2a2f1f
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 989535
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.80(b)Incoming acceptance records, documentation
- 21 CFR 820.80(e)Documentation
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Other FDA inspections of dBMEDx, Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 27, 2025 | NAI | Denver District Office | Postmarket Assurance: Medical Devices |
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