Teledyne E2v Semiconductors
⚠️ Moderate Risk
FEI: 3010665137 • St Egreve • FRANCE
FEI Number
3010665137
Location
St Egreve
Country
FRANCEAddress
Avenue De Rochepleine BP 123, , St Egreve, , France
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 |
|---|---|---|---|
| 3/8/2024 | 76QJKINTRAORAL CAMERA | Division of Southeast Imports (DSEI) | |
| 11/30/2023 | 90ITXTRANSDUCER, ULTRASONIC, DIAGNOSTIC | Division of Southwest Imports (DSWI) | |
| 3/9/2023 | 76EAZLIGHT, OPERATING, DENTAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/22/2010 | 79FWHCAMERA, CINE, SURGICAL, WITHOUT AUDIO | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/19/2010 | 76EAPUNIT, X-RAY, INTRAORAL | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Teledyne E2v Semiconductors's FDA import refusal history?
Teledyne E2v Semiconductors (FEI: 3010665137) has 5 FDA import refusal record(s) in our database, spanning from 5/19/2010 to 3/8/2024.
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. Teledyne E2v Semiconductors's FEI number is 3010665137.
What types of violations has Teledyne E2v Semiconductors received?
Teledyne E2v Semiconductors 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 Teledyne E2v Semiconductors come from?
All FDA import refusal data for Teledyne E2v Semiconductors 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.