FDA Inspection
DJO, LLCDJO, LLC – FDA Inspection, Sep 26, 2017
Record Details
This FDA Inspection record concerns DJO, LLC, with an inspection on September 26, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1c65dd21-e33d-4caa-857b-b35bbd620001
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028586
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
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Other FDA inspections of DJO, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 6, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| July 14, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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