FDA Inspection
Erchonia Corporation, LLCErchonia Corporation, LLC – FDA Inspection, Dec 14, 2018
Record Details
This FDA Inspection record concerns Erchonia Corporation, LLC, with an inspection on December 14, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cd549735-0b09-446a-9978-c33875a336c6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1074668
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.43(c)(5)No financial disclosure info in investigator agreement
- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
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Other FDA inspections of Erchonia Corporation, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2018 | Not classified | Atlanta District Office | |
| May 16, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| 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 1109633 - 2018-10-19
- FDA Inspection 1052145 - 2018-05-16
- FDA Inspection 918047 - 2015-03-12
- FDA Inspection 797366 - 2012-09-05
- FDA Inspection 737607 - 2011-07-29
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