Alphapharma
⚠️ High Risk
FEI: 3005377755 • Baam • NETHERLANDS
FEI Number
3005377755
Location
Baam
Country
NETHERLANDSAddress
Baarnesedijk 1, , Baam, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2005 | 62GCB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 60LCB05ASPIRIN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 66MCB91OXAZEPAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 66MCB91OXAZEPAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 66MCB86LORAZEPAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 62CCB65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 60LCB69TRAMADOL HCL (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 61NDB73MIRTAZAPINE (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 61JCB14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/12/2005 | 61WCB18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Alphapharma's FDA import refusal history?
Alphapharma (FEI: 3005377755) has 10 FDA import refusal record(s) in our database, spanning from 12/12/2005 to 12/12/2005.
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. Alphapharma's FEI number is 3005377755.
What types of violations has Alphapharma received?
Alphapharma has been cited for 1 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 Alphapharma come from?
All FDA import refusal data for Alphapharma 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.