Dishman Netherlands BV
⚠️ High Risk
FEI: 1000352350 • Weesp, Noord-Holland • NETHERLANDS
FEI Number
1000352350
Location
Weesp, Noord-Holland
Country
NETHERLANDSAddress
C J van Houtenlaan 36, , Weesp, Noord-Holland, 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/29/2025 | 65JDA10DYDROGESTERONE (PROGESTIN) | Division of Southeast Imports (DSEI) | |
| 10/30/2009 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | New Orleans District Office (NOL-DO) | |
| 4/9/2008 | 66YCB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/2/2008 | 66SCA03BETAHISTINE HCL (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/18/2005 | 66SDB03BETAHISTINE HCL (VASODILATOR) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 10/8/2002 | 65CIK99NUTRIENT/TONIC N.E.C. | New York District Office (NYK-DO) | |
| 3/28/2002 | 62CIA99ANTI-HYPERTENSIVE N.E.C. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Dishman Netherlands BV's FDA import refusal history?
Dishman Netherlands BV (FEI: 1000352350) has 7 FDA import refusal record(s) in our database, spanning from 3/28/2002 to 9/29/2025.
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. Dishman Netherlands BV's FEI number is 1000352350.
What types of violations has Dishman Netherlands BV received?
Dishman Netherlands BV 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 Dishman Netherlands BV come from?
All FDA import refusal data for Dishman Netherlands 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.