FDA Inspection
Erchonia Corporation, LLCErchonia Corporation, LLC – FDA Inspection, Jul 29, 2011
Record Details
This FDA Inspection record concerns Erchonia Corporation, LLC, with an inspection on July 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Erchonia Corporation, LLC
- Inspection Date
- July 29, 2011
- Product Type
- Devices
View Company Profile
ID · 5f96da98-f510-4040-9ddd-c93f7bd943db
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 737607
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.75(a)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 | |
| 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 |
Other documents for Erchonia Corporation, LLC
- FDA Inspection 1074668 - 2018-12-14
- FDA Inspection 1109633 - 2018-10-19
- FDA Inspection 1052145 - 2018-05-16
- FDA Inspection 918047 - 2015-03-12
- FDA Inspection 797366 - 2012-09-05
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