NWL Netherlands Services B.V.
⚠️ Moderate Risk
FEI: 3003696942 • Hillegom, Zuid-Holland • NETHERLANDS
FEI Number
3003696942
Location
Hillegom, Zuid-Holland
Country
NETHERLANDSAddress
Amperestraat 12, , Hillegom, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/19/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Baltimore District Office (BLT-DO) |
| 8/4/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Baltimore District Office (BLT-DO) |
| 8/4/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Baltimore District Office (BLT-DO) |
| 8/4/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Baltimore District Office (BLT-DO) |
| 8/4/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Baltimore District Office (BLT-DO) |
| 8/4/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Baltimore District Office (BLT-DO) |
| 8/4/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Baltimore District Office (BLT-DO) |
| 8/4/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Baltimore District Office (BLT-DO) |
| 8/4/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Baltimore District Office (BLT-DO) |
| 6/29/2015 | 64ABL20TRICLOSAN (DISINFECTANT) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 6/29/2015 | 64ABL20TRICLOSAN (DISINFECTANT) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 6/4/2015 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Atlanta District Office (ATL-DO) |
| 4/27/2015 | 64ABL20TRICLOSAN (DISINFECTANT) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 4/27/2015 | 64ABL20TRICLOSAN (DISINFECTANT) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 3/19/2015 | 64ABL20TRICLOSAN (DISINFECTANT) | 27DRUG GMPS | Detroit District Office (DET-DO) |
| 7/9/2012 | 61HAL99ANTI-BACTERIAL, N.E.C. | Detroit District Office (DET-DO) | |
| 12/30/2010 | 61HAL99ANTI-BACTERIAL, N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is NWL Netherlands Services B.V.'s FDA import refusal history?
NWL Netherlands Services B.V. (FEI: 3003696942) has 18 FDA import refusal record(s) in our database, spanning from 12/30/2010 to 8/19/2015.
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. NWL Netherlands Services B.V.'s FEI number is 3003696942.
What types of violations has NWL Netherlands Services B.V. received?
NWL Netherlands Services B.V. 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 NWL Netherlands Services B.V. come from?
All FDA import refusal data for NWL Netherlands Services 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.