FDA Inspection
Electro Kinetic Technologies, LLCElectro Kinetic Technologies, LLC – FDA Inspection, Jan 17, 2013
Record Details
This FDA Inspection record concerns Electro Kinetic Technologies, LLC, with an inspection on January 17, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 17, 2013
- Product Type
- Devices
View Company Profile
ID · f19b38aa-f062-4897-a900-3e251abde22e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 815278
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.80(e)Documentation
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 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 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Electro Kinetic Technologies, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 8, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Electro Kinetic Technologies, LLC
- FDA Inspection 1079466 - 2019-02-15
- FDA Inspection 861890 - 2014-01-08
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