Traumec Tecnologia
⚠️ Moderate Risk
FEI: 3010513330 • Rio Claro, Sp • BRAZIL
FEI Number
3010513330
Location
Rio Claro, Sp
Country
BRAZILAddress
Jd R 1a Jsp 138, , Rio Claro, Sp, Brazil
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2014 | 84HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) | New Orleans District Office (NOL-DO) | |
| 1/16/2014 | 79GESBLADE, SCALPEL | New Orleans District Office (NOL-DO) | |
| 1/16/2014 | 79GDIDISSECTOR, SURGICAL, GENERAL & PLASTIC SURGERY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Traumec Tecnologia's FDA import refusal history?
Traumec Tecnologia (FEI: 3010513330) has 3 FDA import refusal record(s) in our database, spanning from 1/16/2014 to 1/16/2014.
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. Traumec Tecnologia's FEI number is 3010513330.
What types of violations has Traumec Tecnologia received?
Traumec Tecnologia has been cited for 3 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 Traumec Tecnologia come from?
All FDA import refusal data for Traumec Tecnologia 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.