Ursapharm Arzneimittel GmbH
⚠️ High Risk
FEI: 3004978466 • Saarbrucken, Saarland • GERMANY
FEI Number
3004978466
Location
Saarbrucken, Saarland
Country
GERMANYAddress
Industriestr. 35, , Saarbrucken, Saarland, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/1/2025 | 62GAY99ANTI-INFLAMMATORY N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 11/21/2025 | 66VBK99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 63NBY04DEXPANTHENOL (CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/10/2025 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2025 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 9/2/2025 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 8/26/2025 | 64DDK02POLYETHYLENE GLYCOL, EMOLLIENT,LUBRICANT | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/21/2025 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/12/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 2/27/2024 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/10/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/8/2023 | 64DBY99EMOLLIENT, LUBRICANT, N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/24/2023 | 64WBK99IRRIGATION SOLUTION N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/24/2023 | 64WBK99IRRIGATION SOLUTION N.E.C. | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/30/2023 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/30/2020 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2018 | 65RAK99REPLENISHER N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2018 | 56KAK10CHLORAMPHENICOL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ursapharm Arzneimittel GmbH's FDA import refusal history?
Ursapharm Arzneimittel GmbH (FEI: 3004978466) has 18 FDA import refusal record(s) in our database, spanning from 12/19/2018 to 12/1/2025.
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. Ursapharm Arzneimittel GmbH's FEI number is 3004978466.
What types of violations has Ursapharm Arzneimittel GmbH received?
Ursapharm Arzneimittel GmbH has been cited for 5 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 Ursapharm Arzneimittel GmbH come from?
All FDA import refusal data for Ursapharm 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.