Wilhelmsen Ships Service Bv
⚠️ Moderate Risk
FEI: 3008506842 • Rotterdam-Albrandswaard, Zuid-Holland • NETHERLANDS
FEI Number
3008506842
Location
Rotterdam-Albrandswaard, Zuid-Holland
Country
NETHERLANDSAddress
Willem Barentszstraat 50, , Rotterdam-Albrandswaard, Zuid-Holland, 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).
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.
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 |
|---|---|---|---|
| 12/29/2015 | 80FPPSTRETCHER, HAND-CARRIED | Florida District Office (FLA-DO) | |
| 9/29/2015 | 80FPPSTRETCHER, HAND-CARRIED | New York District Office (NYK-DO) | |
| 9/1/2015 | 80CBDBOTTLE, COLLECTION, BREATHING SYSTEM (CALIBRATED) | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 9/1/2015 | 80CBDBOTTLE, COLLECTION, BREATHING SYSTEM (CALIBRATED) | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 5/11/2015 | 61TBA99ANTI-EMETIC/NAUSEANT N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Wilhelmsen Ships Service Bv's FDA import refusal history?
Wilhelmsen Ships Service Bv (FEI: 3008506842) has 5 FDA import refusal record(s) in our database, spanning from 5/11/2015 to 12/29/2015.
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. Wilhelmsen Ships Service Bv's FEI number is 3008506842.
What types of violations has Wilhelmsen Ships Service Bv received?
Wilhelmsen Ships Service Bv 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 Wilhelmsen Ships Service Bv come from?
All FDA import refusal data for Wilhelmsen Ships Service Bv 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.