FDA Inspection
LED Technologies, LLCLED Technologies, LLC – FDA Inspection, Sep 25, 2012
Record Details
This FDA Inspection record concerns LED Technologies, LLC, with an inspection on September 25, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LED Technologies, LLC
- Inspection Date
- September 25, 2012
- Product Type
- Devices
View Company Profile
ID · 71428b0c-c1b1-4170-ab72-07ce52214875
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 800774
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
11- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(e)Records of complaint investigation
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Other FDA inspections of LED Technologies, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 30, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 22, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for LED Technologies, LLC
- FDA Inspection 1048041 - 2018-04-12
- FDA Inspection 981430 - 2016-06-30
- FDA Inspection 579085 - 2009-04-22
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