Nazr Osman
⚠️ Moderate Risk
FEI: 3004482776 • Jeddah • SAUDI ARABIA
FEI Number
3004482776
Location
Jeddah
Country
SAUDI ARABIAAddress
Po Box 11629, , Jeddah, , Saudi Arabia
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).
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 |
|---|---|---|---|
| 4/1/2004 | 61PCA26METFORMIN (ANTI-DIABETIC) | New York District Office (NYK-DO) | |
| 4/1/2004 | 63ACA02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | New York District Office (NYK-DO) | |
| 4/1/2004 | 88LDTREAGENT, GENERAL PURPOSE | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Nazr Osman's FDA import refusal history?
Nazr Osman (FEI: 3004482776) has 3 FDA import refusal record(s) in our database, spanning from 4/1/2004 to 4/1/2004.
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. Nazr Osman's FEI number is 3004482776.
What types of violations has Nazr Osman received?
Nazr Osman has been cited for 2 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 Nazr Osman come from?
All FDA import refusal data for Nazr Osman 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.