Al Amri Ast
⚠️ Moderate Risk
FEI: 3009074592 • Jeddah • SAUDI ARABIA
FEI Number
3009074592
Location
Jeddah
Country
SAUDI ARABIAAddress
60th Street, Babab Sharif, , 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 |
|---|---|---|---|
| 9/13/2011 | 53DC03POWDERS (DUSTING AND TALCUM, EXCLUDING AFTERSHAVE TALC) (FRAGRANCE PREPARATIONS) | 473LABELING | Southwest Import District Office (SWI-DO) |
| 9/13/2011 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Al Amri Ast's FDA import refusal history?
Al Amri Ast (FEI: 3009074592) has 2 FDA import refusal record(s) in our database, spanning from 9/13/2011 to 9/13/2011.
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 Amri Ast's FEI number is 3009074592.
What types of violations has Al Amri Ast received?
Al Amri Ast has been cited for 4 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 Amri Ast come from?
All FDA import refusal data for Al Amri Ast 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.