TOP CLEAN INJECTION
⚠️ Moderate Risk
FEI: 3007017524 • Peschadoires, Puy de Dome • FRANCE
FEI Number
3007017524
Location
Peschadoires, Puy de Dome
Country
FRANCEAddress
Zone Industrielle Les Torrents, ZONE DE HAUTES TECHNOLOGIES, 14 RUE DE LINNOVATION, Peschadoires, Puy de Dome, France
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2015 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | New Orleans District Office (NOL-DO) | |
| 12/24/2014 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | New York District Office (NYK-DO) | |
| 12/9/2014 | 79GAANEEDLE, ASPIRATION AND INJECTION, DISPOSABLE | New Orleans District Office (NOL-DO) | |
| 10/23/2012 | 86NCEINJECTOR, CAPSULAR TENSION RING | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is TOP CLEAN INJECTION's FDA import refusal history?
TOP CLEAN INJECTION (FEI: 3007017524) has 4 FDA import refusal record(s) in our database, spanning from 10/23/2012 to 3/16/2015.
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. TOP CLEAN INJECTION's FEI number is 3007017524.
What types of violations has TOP CLEAN INJECTION received?
TOP CLEAN INJECTION 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 TOP CLEAN INJECTION come from?
All FDA import refusal data for TOP CLEAN INJECTION 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.