FDA Inspection
Erchonia Corporation, LLCErchonia Corporation, LLC – FDA Inspection, May 16, 2018
Record Details
This FDA Inspection record concerns Erchonia Corporation, LLC, with an inspection on May 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7a8fd184-4c85-4278-b578-a7277ae9d8a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1052145
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(c)Documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Erchonia Corporation, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2018 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 19, 2018 | Not classified | Atlanta District Office | |
| March 12, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 5, 2012 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| July 29, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Erchonia Corporation, LLC
- FDA Inspection 1074668 - 2018-12-14
- FDA Inspection 1109633 - 2018-10-19
- FDA Inspection 918047 - 2015-03-12
- FDA Inspection 797366 - 2012-09-05
- FDA Inspection 737607 - 2011-07-29
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