Desarrollos Tecnicos Gtri
⚠️ Moderate Risk
FEI: 3006479675 • Madrid, Madrid • SPAIN
FEI Number
3006479675
Location
Madrid, Madrid
Country
SPAINAddress
Nave 29, Calle Luis I 71, Madrid, Madrid, Spain
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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/31/2009 | 80MTVSHARPS NEEDLE DESTRUCTION DEVICE | Florida District Office (FLA-DO) | |
| 11/19/2008 | 80MTVSHARPS NEEDLE DESTRUCTION DEVICE | Florida District Office (FLA-DO) | |
| 10/16/2007 | 80MTVSHARPS NEEDLE DESTRUCTION DEVICE | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Desarrollos Tecnicos Gtri's FDA import refusal history?
Desarrollos Tecnicos Gtri (FEI: 3006479675) has 3 FDA import refusal record(s) in our database, spanning from 10/16/2007 to 3/31/2009.
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. Desarrollos Tecnicos Gtri's FEI number is 3006479675.
What types of violations has Desarrollos Tecnicos Gtri received?
Desarrollos Tecnicos Gtri 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 Desarrollos Tecnicos Gtri come from?
All FDA import refusal data for Desarrollos Tecnicos Gtri 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.