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Invatec Technology Center

⚠️ High Risk

FEI: 3008383870 • Frauenfeld, Thurgau • SWITZERLAND

FEI

FEI Number

3008383870

📍

Location

Frauenfeld, Thurgau

🇨🇭
🏢

Address

Hungerbuelstrasse 12a, , Frauenfeld, Thurgau, Switzerland

High Risk

FDA Import Risk Assessment

52.5
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

19
Total Refusals
1
Unique Violations
9/9/2013
Latest Refusal
9/9/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
48.2×30%
Recency
0.0×20%
Frequency
100.0×10%
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

278019×

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

DateProductViolationsDivision
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 Technology Center's FDA import refusal history?

Invatec Technology Center (FEI: 3008383870) has 19 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 Technology Center's FEI number is 3008383870.

What types of violations has Invatec Technology Center received?

Invatec Technology Center 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 Technology Center come from?

All FDA import refusal data for Invatec Technology Center 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.