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Abbott Arzneimittel Gmbh

✅ Low Risk

FEI: 3010288478 • Hannover, Niedersachsen • GERMANY

FEI

FEI Number

3010288478

📍

Location

Hannover, Niedersachsen

🇩🇪

Country

GERMANY
🏢

Address

Freundallee 9a, , Hannover, Niedersachsen, Germany

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
8/13/2013
Latest Refusal
8/13/2013
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
8/13/2013
66SDB03BETAHISTINE HCL (VASODILATOR)
472NO ENGLISH
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is Abbott Arzneimittel Gmbh's FDA import refusal history?

Abbott Arzneimittel Gmbh (FEI: 3010288478) has 1 FDA import refusal record(s) in our database, spanning from 8/13/2013 to 8/13/2013.

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. Abbott Arzneimittel Gmbh's FEI number is 3010288478.

What types of violations has Abbott Arzneimittel Gmbh received?

Abbott Arzneimittel Gmbh 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 Abbott Arzneimittel Gmbh come from?

All FDA import refusal data for Abbott Arzneimittel Gmbh 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.