Haupt Pharma Wuelfing GmbH
⚠️ High Risk
FEI: 3003183252 • Gronau (Leine), Lower Saxony • GERMANY
FEI Number
3003183252
Location
Gronau (Leine), Lower Saxony
Country
GERMANYAddress
Bethelner Landstr. 18, , Gronau (Leine), Lower Saxony, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2025 | 65NCB07CESIUM CHLORIDE CS 131 (RADIOACTIVE AGENT) | Division of Southeast Imports (DSEI) | |
| 1/10/2024 | 56ECS61MINOCYCLINE HYDROCHLORIDE (TETRACYCLINES) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/10/2024 | 56ECS61MINOCYCLINE HYDROCHLORIDE (TETRACYCLINES) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/9/2020 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/14/2005 | 66VBB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Haupt Pharma Wuelfing GmbH's FDA import refusal history?
Haupt Pharma Wuelfing GmbH (FEI: 3003183252) has 5 FDA import refusal record(s) in our database, spanning from 3/14/2005 to 6/13/2025.
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. Haupt Pharma Wuelfing GmbH's FEI number is 3003183252.
What types of violations has Haupt Pharma Wuelfing GmbH received?
Haupt Pharma Wuelfing GmbH 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 Haupt Pharma Wuelfing GmbH come from?
All FDA import refusal data for Haupt Pharma Wuelfing 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.