Sopro Comeg Gmbh
⚠️ Moderate Risk
FEI: 3005840432 • Tuttlingen, Baden-wurttemberg • GERMANY
FEI Number
3005840432
Location
Tuttlingen, Baden-wurttemberg
Country
GERMANYAddress
Dornierstr. 55, , Tuttlingen, Baden-wurttemberg, Germany
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
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.
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).
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
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 |
|---|---|---|---|
| 7/23/2024 | 78FGBURETEROSCOPE | Division of Southeast Imports (DSEI) | |
| 1/22/2015 | 87HRXARTHROSCOPE AND ACCESSORIES | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/16/2015 | 87HRXARTHROSCOPE AND ACCESSORIES | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 1/16/2015 | 87HRXARTHROSCOPE AND ACCESSORIES | 3724DEVGMPS | Division of Southeast Imports (DSEI) |
| 1/7/2015 | 77EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 1/7/2015 | 77EOBNASOPHARYNGOSCOPE (FLEXIBLE OR RIGID) | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 6/11/2013 | 78FAJCYSTOSCOPE, DIAGNOSTIC | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 11/5/2010 | 78GCNENDOSCOPE, PRISM | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sopro Comeg Gmbh's FDA import refusal history?
Sopro Comeg Gmbh (FEI: 3005840432) has 8 FDA import refusal record(s) in our database, spanning from 11/5/2010 to 7/23/2024.
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. Sopro Comeg Gmbh's FEI number is 3005840432.
What types of violations has Sopro Comeg Gmbh received?
Sopro Comeg Gmbh has been cited for 5 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 Sopro Comeg Gmbh come from?
All FDA import refusal data for Sopro Comeg Gmbh 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.