SAS ETABLISSEMENTS MAURICE MARLE
⚠️ Moderate Risk
FEI: 3010576282 • Nogent, Haute Marne • FRANCE
FEI Number
3010576282
Location
Nogent, Haute Marne
Country
FRANCEAddress
ZI RUE LAVOISIER, BP 46, , Nogent, Haute Marne, 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
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.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
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 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 |
|---|---|---|---|
| 5/18/2018 | 87LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED | Division of Northern Border Imports (DNBI) | |
| 5/11/2018 | 87LZOPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/POLYMER, CEMENTED OR NON-POROUS, UNCEMENTED | Division of Northern Border Imports (DNBI) | |
| 3/30/2017 | 87MRAPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED | New Orleans District Office (NOL-DO) | |
| 3/30/2017 | 87MRAPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED | New Orleans District Office (NOL-DO) | |
| 3/30/2017 | 87MRAPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED | New Orleans District Office (NOL-DO) | |
| 3/30/2017 | 87MRAPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED | New Orleans District Office (NOL-DO) | |
| 3/30/2017 | 87MRAPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/CERAMIC/CERAMIC/METAL, CEMENTED OR UNCEMENTED | New Orleans District Office (NOL-DO) | |
| 6/19/2012 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is SAS ETABLISSEMENTS MAURICE MARLE's FDA import refusal history?
SAS ETABLISSEMENTS MAURICE MARLE (FEI: 3010576282) has 8 FDA import refusal record(s) in our database, spanning from 6/19/2012 to 5/18/2018.
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. SAS ETABLISSEMENTS MAURICE MARLE's FEI number is 3010576282.
What types of violations has SAS ETABLISSEMENTS MAURICE MARLE received?
SAS ETABLISSEMENTS MAURICE MARLE 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 SAS ETABLISSEMENTS MAURICE MARLE come from?
All FDA import refusal data for SAS ETABLISSEMENTS MAURICE MARLE 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.