Invatec Innovative Technologies S.P.A.
⚠️ High Risk
FEI: 3008529968 • Roncadelle, Brescia • ITALY
FEI Number
3008529968
Location
Roncadelle, Brescia
Country
ITALYAddress
Via Industriale 26, , Roncadelle, Brescia, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
| 9/9/2013 | 74DQYCATHETER, PERCUTANEOUS | 2780DEVICEGMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Invatec Innovative Technologies S.P.A.'s FDA import refusal history?
Invatec Innovative Technologies S.P.A. (FEI: 3008529968) has 55 FDA import refusal record(s) in our database, spanning from 9/9/2013 to 9/9/2013.
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. Invatec Innovative Technologies S.P.A.'s FEI number is 3008529968.
What types of violations has Invatec Innovative Technologies S.P.A. received?
Invatec Innovative Technologies S.P.A. has been cited for 1 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 Invatec Innovative Technologies S.P.A. come from?
All FDA import refusal data for Invatec Innovative Technologies S.P.A. 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.