FDA Inspection
DJO, LLCDJO, LLC – FDA Inspection, Sep 6, 2013
Record Details
This FDA Inspection record concerns DJO, LLC, with an inspection on September 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DJO, LLC
- Inspection Date
- September 6, 2013
- Product Type
- Devices
View Company Profile
ID · cba7d30a-a173-42f4-ad01-e468321478d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848742
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - 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 26, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 14, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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