European Medical Contract Mfg.
⚠️ Moderate Risk
FEI: 3002806942 • Nijmegen, Gelderland • NETHERLANDS
FEI Number
3002806942
Location
Nijmegen, Gelderland
Country
NETHERLANDSAddress
Middenkampweg 17, , Nijmegen, Gelderland, Netherlands
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).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2017 | 87LODBONE CEMENT | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 3/29/2017 | 87LODBONE CEMENT | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 6/5/2013 | 87LODBONE CEMENT | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 6/5/2013 | 87LODBONE CEMENT | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 3/15/2013 | 87LODBONE CEMENT | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 3/15/2013 | 87LODBONE CEMENT | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 3/15/2013 | 87LODBONE CEMENT | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 3/15/2013 | 87LODBONE CEMENT | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 1/15/2013 | 89MLQINHIBITOR, PERIDURAL FIBROSIS (ADHESION BARRIER) | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | New Orleans District Office (NOL-DO) | |
| 1/9/2009 | 87LODBONE CEMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/9/2009 | 87LODBONE CEMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/9/2009 | 87LODBONE CEMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/9/2009 | 87LODBONE CEMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 1/9/2009 | 87LODBONE CEMENT | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 7/23/2008 | 89MBPFILLER, BONE VOID, OSTEOINDUCTION (W/O HUMAN GROWTH FACTOR) | 2380NO PMA/PDP | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is European Medical Contract Mfg.'s FDA import refusal history?
European Medical Contract Mfg. (FEI: 3002806942) has 32 FDA import refusal record(s) in our database, spanning from 7/23/2008 to 3/29/2017.
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. European Medical Contract Mfg.'s FEI number is 3002806942.
What types of violations has European Medical Contract Mfg. received?
European Medical Contract Mfg. 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 European Medical Contract Mfg. come from?
All FDA import refusal data for European Medical Contract Mfg. 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.