Erchonia Corporation, LLC
⚠️ Moderate Risk
FEI: 3003462036 • Fountain Inn, SC • UNITED STATES
FEI Number
3003462036
Location
Fountain Inn, SC
Country
UNITED STATESAddress
112 Southchase Blvd, , Fountain Inn, SC, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/6/2016 | 79OLIFAT REDUCING LOW LEVEL LASER | Los Angeles District Office (LOS-DO) | |
| 4/13/2012 | 79OYWFOR THE REMOVAL OF FAT THROUGH LASER LIPOLYSIS | 476NO REGISTR | Florida District Office (FLA-DO) |
| 9/14/2006 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Erchonia Corporation, LLC's FDA import refusal history?
Erchonia Corporation, LLC (FEI: 3003462036) has 3 FDA import refusal record(s) in our database, spanning from 9/14/2006 to 4/6/2016.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Erchonia Corporation, LLC's FEI number is 3003462036.
What types of violations has Erchonia Corporation, LLC received?
Erchonia Corporation, LLC has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Erchonia Corporation, LLC come from?
All FDA import refusal data for Erchonia Corporation, LLC is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.