FA. HEUMANN
⚠️ High Risk
FEI: 3031512553 • Nuremberg • GERMANY
FEI Number
3031512553
Location
Nuremberg
Country
GERMANYAddress
Suedwestpark 50, , Nuremberg, , Germany
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/25/2024 | 62FBJ99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2024 | 62ODB19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/25/2024 | 61LDB38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FA. HEUMANN's FDA import refusal history?
FA. HEUMANN (FEI: 3031512553) has 3 FDA import refusal record(s) in our database, spanning from 8/25/2024 to 8/25/2024.
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. FA. HEUMANN's FEI number is 3031512553.
What types of violations has FA. HEUMANN received?
FA. HEUMANN 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 FA. HEUMANN come from?
All FDA import refusal data for FA. HEUMANN 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.