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Asia-Med Gesellschaft Fur Akupunkturbeda

⚠️ Moderate Risk

FEI: 3003768614 • Suhl, Thuringia • GERMANY

FEI

FEI Number

3003768614

📍

Location

Suhl, Thuringia

🇩🇪

Country

GERMANY
🏢

Address

Schutzenstr. 22, , Suhl, Thuringia, Germany

Moderate Risk

FDA Import Risk Assessment

27.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
9/26/2013
Latest Refusal
9/26/2013
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2233×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

3413×

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).

Refusal History

DateProductViolationsDivision
9/26/2013
80MQXNEEDLE, ACUPUNCTURE, SINGLE USE
223FALSE
341REGISTERED
New York District Office (NYK-DO)
9/26/2013
80MQXNEEDLE, ACUPUNCTURE, SINGLE USE
223FALSE
341REGISTERED
New York District Office (NYK-DO)
9/26/2013
80MQXNEEDLE, ACUPUNCTURE, SINGLE USE
223FALSE
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Asia-Med Gesellschaft Fur Akupunkturbeda's FDA import refusal history?

Asia-Med Gesellschaft Fur Akupunkturbeda (FEI: 3003768614) has 3 FDA import refusal record(s) in our database, spanning from 9/26/2013 to 9/26/2013.

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. Asia-Med Gesellschaft Fur Akupunkturbeda's FEI number is 3003768614.

What types of violations has Asia-Med Gesellschaft Fur Akupunkturbeda received?

Asia-Med Gesellschaft Fur Akupunkturbeda 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 Asia-Med Gesellschaft Fur Akupunkturbeda come from?

All FDA import refusal data for Asia-Med Gesellschaft Fur Akupunkturbeda 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.