FDA Inspection
DJO, LLCDJO, LLC – FDA Inspection, Jul 14, 2011
Record Details
This FDA Inspection record concerns DJO, LLC, with an inspection on July 14, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DJO, LLC
- Inspection Date
- July 14, 2011
- Product Type
- Devices
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ID · f91b5f9d-dd44-4419-b8fb-d69dbbb8be4e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 735208
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.72(b)Remedial action
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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 |
| September 6, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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