Fresenius Hemocare Netherlands B.V
⚠️ Moderate Risk
FEI: 3002807758 • Emmer-compascuum, Drenthe • NETHERLANDS
FEI Number
3002807758
Location
Emmer-compascuum, Drenthe
Country
NETHERLANDSAddress
Runde Zz 41, , Emmer-compascuum, Drenthe, Netherlands
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
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
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 |
|---|---|---|---|
| 1/12/2007 | 65HCN04HETASTARCH (PLASMA VOLUME EXTENDER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/17/2005 | 78LKNAUTOMATED BLOOD CELL AND PLASMA SEPARATOR FOR THERAPEUTIC PURPOSES, CENTRIFUGE | Seattle District Office (SEA-DO) | |
| 10/24/2005 | 78LKNAUTOMATED BLOOD CELL AND PLASMA SEPARATOR FOR THERAPEUTIC PURPOSES, CENTRIFUGE | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Fresenius Hemocare Netherlands B.V's FDA import refusal history?
Fresenius Hemocare Netherlands B.V (FEI: 3002807758) has 3 FDA import refusal record(s) in our database, spanning from 10/24/2005 to 1/12/2007.
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. Fresenius Hemocare Netherlands B.V's FEI number is 3002807758.
What types of violations has Fresenius Hemocare Netherlands B.V received?
Fresenius Hemocare Netherlands 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 Fresenius Hemocare Netherlands B.V come from?
All FDA import refusal data for Fresenius Hemocare Netherlands 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.