Saudi Aramco Medical
⚠️ Moderate Risk
FEI: 3005386642 • Udhailiyah • SAUDI ARABIA
FEI Number
3005386642
Location
Udhailiyah
Country
SAUDI ARABIAAddress
P.O.Box 8410, , Udhailiyah, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2005 | 62UBA99ANTI-TUSSIVE/COLD N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/2/2005 | 60LAL01ACETAMINOPHEN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/2/2005 | 60LAA05ASPIRIN (ANALGESIC) | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/2/2005 | 56ICL76AZITHROMYCIN (MACAROLIDES) | 118NOT LISTED | New York District Office (NYK-DO) |
| 12/2/2005 | 56BCL03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Saudi Aramco Medical's FDA import refusal history?
Saudi Aramco Medical (FEI: 3005386642) has 5 FDA import refusal record(s) in our database, spanning from 12/2/2005 to 12/2/2005.
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. Saudi Aramco Medical's FEI number is 3005386642.
What types of violations has Saudi Aramco Medical received?
Saudi Aramco Medical 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 Saudi Aramco Medical come from?
All FDA import refusal data for Saudi Aramco Medical 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.