Omer Basebrain
⚠️ High Risk
FEI: 3005997006 • Jeddah • SAUDI ARABIA
FEI Number
3005997006
Location
Jeddah
Country
SAUDI ARABIAAddress
Alaziziah Dist, , Jeddah, , Saudi Arabia
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 |
|---|---|---|---|
| 12/15/2006 | 54AFB04VITAMIN B6 (PYRIDOXINE) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 61XCA99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 66RAA99VASOCONSTRICTOR N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 61JCB11GEMFIBROZIL (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 65VCB10CHLORDIAZEPOXIDE HCL (SEDATIVE) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 61VCA01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 60SCB07PRECIPITATED CALCIUM CARBONATE (ANTACID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 63ACB99BONE CALCIUM REGULATOR N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 66SCB03BETAHISTINE HCL (VASODILATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 60SCB25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 60XCB17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 66SCB27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 64LCB50PREDNISOLONE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 60LCB01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 62GCA89CYCLOSPORINE (ANTI-INFLAMMATORY) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 64TCF04MYCOPHENOLATE MOFETIL (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/6/2006 | 56BCB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Omer Basebrain's FDA import refusal history?
Omer Basebrain (FEI: 3005997006) has 18 FDA import refusal record(s) in our database, spanning from 12/6/2006 to 12/15/2006.
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. Omer Basebrain's FEI number is 3005997006.
What types of violations has Omer Basebrain received?
Omer Basebrain 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 Omer Basebrain come from?
All FDA import refusal data for Omer Basebrain 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.