RM ET ASSOCIES
✅ Low Risk
FEI: 3008020771 • Paris 10e Arrondissement, Paris • FRANCE
FEI Number
3008020771
Location
Paris 10e Arrondissement, Paris
Country
FRANCEAddress
42 Quai De Jemmapes, , Paris 10e Arrondissement, Paris, France
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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).
WRONG IDEN
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 403(b) of the FD&C Act. The article appears to be offered for sale under the name of another food.
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/10/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/27/2012 | 80KMJLUBRICANT, PATIENT | Philadelphia District Office (PHI-DO) | |
| 5/5/2010 | 33UFT02CHEWING GUM (WITHOUT CHOCOLATE) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is RM ET ASSOCIES's FDA import refusal history?
RM ET ASSOCIES (FEI: 3008020771) has 3 FDA import refusal record(s) in our database, spanning from 5/5/2010 to 12/10/2015.
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. RM ET ASSOCIES's FEI number is 3008020771.
What types of violations has RM ET ASSOCIES received?
RM ET ASSOCIES 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 RM ET ASSOCIES come from?
All FDA import refusal data for RM ET ASSOCIES 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.