Aspen Bad Oldesloe Gmbh
⚠️ Moderate Risk
FEI: 3008805359 • Bad Oldesloe, Schleswig-Holstein • GERMANY
FEI Number
3008805359
Location
Bad Oldesloe, Schleswig-Holstein
Country
GERMANYAddress
Industrie Str. 32-36, , Bad Oldesloe, Schleswig-Holstein, Germany
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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).
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 |
|---|---|---|---|
| 11/14/2024 | 66TDY01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/14/2024 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 61GDL57SULFAMETHOXAZOLE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/22/2015 | 62GDB86ALLOPURINOL SODIUM (ANTI-INFLAMMATORY) | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Aspen Bad Oldesloe Gmbh's FDA import refusal history?
Aspen Bad Oldesloe Gmbh (FEI: 3008805359) has 4 FDA import refusal record(s) in our database, spanning from 5/22/2015 to 11/14/2024.
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. Aspen Bad Oldesloe Gmbh's FEI number is 3008805359.
What types of violations has Aspen Bad Oldesloe Gmbh received?
Aspen Bad Oldesloe Gmbh has been cited for 3 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 Aspen Bad Oldesloe Gmbh come from?
All FDA import refusal data for Aspen Bad Oldesloe 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.