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HAMELN PHARMACEUTICALS GMBH.

⚠️ Moderate Risk

FEI: 3014489852 • Hameln, Lower Saxony • GERMANY

FEI

FEI Number

3014489852

📍

Location

Hameln, Lower Saxony

🇩🇪

Country

GERMANY
🏢

Address

Langes Feld 13, , Hameln, Lower Saxony, Germany

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/21/2021
Latest Refusal
2/21/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

753×

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
2/21/2021
66YDK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of Southwest Imports (DSWI)
2/21/2021
66YDK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of West Coast Imports (DWCI)
2/21/2021
66YDK99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is HAMELN PHARMACEUTICALS GMBH.'s FDA import refusal history?

HAMELN PHARMACEUTICALS GMBH. (FEI: 3014489852) has 3 FDA import refusal record(s) in our database, spanning from 2/21/2021 to 2/21/2021.

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. HAMELN PHARMACEUTICALS GMBH.'s FEI number is 3014489852.

What types of violations has HAMELN PHARMACEUTICALS GMBH. received?

HAMELN PHARMACEUTICALS 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 HAMELN PHARMACEUTICALS GMBH. come from?

All FDA import refusal data for HAMELN PHARMACEUTICALS 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.