COMEPA INDUSTRIES
⚠️ High Risk
FEI: 3007582665 • Bagnoles • FRANCE
FEI Number
3007582665
Location
Bagnoles
Country
FRANCEAddress
88 Avenue Du General De Gaulle, , Bagnoles, , France
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/17/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/17/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/17/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/17/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/17/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/13/2022 | 79GDXSCALPEL, ONE-PIECE | Division of Southeast Imports (DSEI) | |
| 1/18/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/18/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/18/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/18/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/18/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/18/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/18/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/18/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/11/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/11/2022 | 79GDXSCALPEL, ONE-PIECE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is COMEPA INDUSTRIES's FDA import refusal history?
COMEPA INDUSTRIES (FEI: 3007582665) has 16 FDA import refusal record(s) in our database, spanning from 1/11/2022 to 10/17/2022.
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. COMEPA INDUSTRIES's FEI number is 3007582665.
What types of violations has COMEPA INDUSTRIES received?
COMEPA INDUSTRIES has been cited for 2 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 COMEPA INDUSTRIES come from?
All FDA import refusal data for COMEPA INDUSTRIES 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.