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Hevert Arzneimittel GmbH & Co. KG

⚠️ Moderate Risk

FEI: 3010165877 • Nusbaum, Rhineland-Palatinate • GERMANY

FEI

FEI Number

3010165877

📍

Location

Nusbaum, Rhineland-Palatinate

🇩🇪

Country

GERMANY
🏢

Address

In der Weiherwiese 1, , Nusbaum, Rhineland-Palatinate, Germany

Moderate Risk

FDA Import Risk Assessment

44.3
LowModerateHighCritical

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

Statistics

8
Total Refusals
2
Unique Violations
6/4/2021
Latest Refusal
6/8/2009
Earliest Refusal

Score Breakdown

Violation Severity
82.5×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
6.7×10%
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

757×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

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
6/4/2021
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/19/2020
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
11/19/2020
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
11/19/2020
61VCA99ANTI-FLATULENT N.E.C.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
11/19/2020
61VCA99ANTI-FLATULENT N.E.C.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
11/19/2020
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
11/19/2020
60QCL46PROCAINE HCL (ANESTHETIC)
75UNAPPROVED
Division of Northern Border Imports (DNBI)
6/8/2009
62TDK06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY)
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Hevert Arzneimittel GmbH & Co. KG's FDA import refusal history?

Hevert Arzneimittel GmbH & Co. KG (FEI: 3010165877) has 8 FDA import refusal record(s) in our database, spanning from 6/8/2009 to 6/4/2021.

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. Hevert Arzneimittel GmbH & Co. KG's FEI number is 3010165877.

What types of violations has Hevert Arzneimittel GmbH & Co. KG received?

Hevert Arzneimittel GmbH & Co. KG 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 Hevert Arzneimittel GmbH & Co. KG come from?

All FDA import refusal data for Hevert Arzneimittel GmbH & Co. KG 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.