FDA Inspection
Denali R & D CorporationDenali R & D Corporation – FDA Inspection, Jul 12, 2017
Record Details
This FDA Inspection record concerns Denali R & D Corporation, with an inspection on July 12, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 373f916c-44f1-458b-abd8-464c3f399718
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017929
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Denali R & D Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 6, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 1, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Denali R & D Corporation
- FDA Inspection 1154255 - 2021-10-06
- FDA Inspection 785239 - 2012-06-01
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