Al-Shefah Oasis Medical Herbs
⚠️ Moderate Risk
FEI: 3009426471 • Dubai • UNITED ARAB EMIRATES
FEI Number
3009426471
Location
Dubai
Country
UNITED ARAB EMIRATESAddress
Po Box 84058, , Dubai, , United Arab Emirates
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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
Frequently Asked Questions
What is Al-Shefah Oasis Medical Herbs's FDA import refusal history?
Al-Shefah Oasis Medical Herbs (FEI: 3009426471) has 1 FDA import refusal record(s) in our database, spanning from 12/16/2020 to 12/16/2020.
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. Al-Shefah Oasis Medical Herbs's FEI number is 3009426471.
What types of violations has Al-Shefah Oasis Medical Herbs received?
Al-Shefah Oasis Medical Herbs 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 Al-Shefah Oasis Medical Herbs come from?
All FDA import refusal data for Al-Shefah Oasis Medical Herbs 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.