Rodea S.A.S.
⚠️ Moderate Risk
FEI: 3010932994 • Pecetto Torinese, To • ITALY
FEI Number
3010932994
Location
Pecetto Torinese, To
Country
ITALYAddress
Strada Antegnasco 5, , Pecetto Torinese, To, Italy
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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/18/2014 | 76EMGFORCEPS, TOOTH EXTRACTOR, SURGICAL | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 76EGNSCISSORS, SURGICAL TISSUE, DENTAL | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 76DZNMATRIX, DENTAL | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 76EKICARRIER, AMALGAM, OPERATIVE | New Orleans District Office (NOL-DO) | |
| 12/18/2014 | 76OFXGENERAL PURPOSE DENTAL TRAY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Rodea S.A.S.'s FDA import refusal history?
Rodea S.A.S. (FEI: 3010932994) has 5 FDA import refusal record(s) in our database, spanning from 12/18/2014 to 12/18/2014.
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. Rodea S.A.S.'s FEI number is 3010932994.
What types of violations has Rodea S.A.S. received?
Rodea S.A.S. 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 Rodea S.A.S. come from?
All FDA import refusal data for Rodea S.A.S. 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.