Company
United StatesErchonia Corporation, LLC, Fountain Inn, SC – FDA Inspections
Inspection records and compliance data for Erchonia Corporation, LLC in Fountain Inn, South Carolina. 8 FDA inspections on record (3 OAI), 3 Form 483s, last inspected December 14, 2018.
Company Profile
This profile covers Erchonia Corporation, LLC based in Fountain Inn, South Carolina, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 3
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 3
- Warning letters
- 0
First inspected November 24, 2009. Last inspected December 14, 2018.
Most cited issue areas
- Documentation2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Lack of or inadequate DHR procedures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 14, 2018 | OAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1074668 |
| October 19, 2018 | Not classified | Medical Devices & Rad Health | 1109633 |
| May 16, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1052145 |
| March 12, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 918047 |
| September 5, 2012 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 797366 |
| July 29, 2011 | OAI | Medical Devices & Rad Health · Compliance: Devices | 737607 |
| July 20, 2010 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 673651 |
| November 24, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 630051 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Erchonia Corporation, LLC
FEI Number
3003462036
Address
112 Southchase Blvd, Fountain Inn, South Carolina 29644, United States
Country
United States
ID: fa943c5a-870a-4cc5-90cd-a62c3e0b8332