FDA Inspection
Durden Enterprises, LTD.Durden Enterprises, LTD. – FDA Inspection, Sep 15, 2009
Record Details
This FDA Inspection record concerns Durden Enterprises, LTD., with an inspection on September 15, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Durden Enterprises, LTD.
- Inspection Date
- September 15, 2009
- Product Type
- Devices
View Company Profile
ID · 8ac3d8a5-9aec-49eb-9edc-c3f159a6a157
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 620117
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(a)(3)Processing MDRs {see also 803, 804}
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Specific non-conforming product procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
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Other FDA inspections of Durden Enterprises, LTD.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Durden Enterprises, LTD.
- FDA Inspection 846616 - 2013-08-22
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