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Cheplapharm Arzneimittel GmbH

⚠️ Moderate Risk

FEI: 3005686546 • Hansestadt, Mecklenburg-Western-Pommerania • GERMANY

FEI

FEI Number

3005686546

📍

Location

Hansestadt, Mecklenburg-Western-Pommerania

🇩🇪

Country

GERMANY
🏢

Address

Ziegelhof 24, , Greifswald, Hansestadt, Mecklenburg-Western-Pommerania, Germany

Moderate Risk

FDA Import Risk Assessment

45.3
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
8/12/2016
Latest Refusal
2/9/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
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

755×

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).

Refusal History

DateProductViolationsDivision
8/12/2016
63NCA25URSODIOL (CHOLINERGIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/9/2009
66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/9/2009
66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/9/2009
66VDL99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
2/9/2009
66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Cheplapharm Arzneimittel GmbH's FDA import refusal history?

Cheplapharm Arzneimittel GmbH (FEI: 3005686546) has 5 FDA import refusal record(s) in our database, spanning from 2/9/2009 to 8/12/2016.

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. Cheplapharm Arzneimittel GmbH's FEI number is 3005686546.

What types of violations has Cheplapharm Arzneimittel GmbH received?

Cheplapharm 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 Cheplapharm Arzneimittel GmbH come from?

All FDA import refusal data for Cheplapharm 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.