Aspen Oss B.V.
⚠️ High Risk
FEI: 3010414279 • Oss, Noord-Brabant • NETHERLANDS
FEI Number
3010414279
Location
Oss, Noord-Brabant
Country
NETHERLANDSAddress
Kloosterstraat 6, , Oss, Noord-Brabant, Netherlands
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 10/7/2025 | 64MCY07FOLLISTIM (FOLLITROPIN BETA(RDNA)) (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/29/2021 | 64PDY04TRANEXAMIC ACID (HEMOSTATIC) | Division of Southeast Imports (DSEI) | |
| 7/5/2019 | 56YYY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/5/2019 | 56YYY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/5/2019 | 56YYY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 7/9/2014 | 65DCS99OXYTOCIC N.E.C. | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Aspen Oss B.V.'s FDA import refusal history?
Aspen Oss B.V. (FEI: 3010414279) has 6 FDA import refusal record(s) in our database, spanning from 7/9/2014 to 10/7/2025.
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. Aspen Oss B.V.'s FEI number is 3010414279.
What types of violations has Aspen Oss B.V. received?
Aspen Oss B.V. has been cited for 4 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 Oss B.V. come from?
All FDA import refusal data for Aspen Oss B.V. 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.