Mujezat Al Shifa General Trading Co
⚠️ Moderate Risk
FEI: 3010811895 • Salmiya • KUWAIT
FEI Number
3010811895
Location
Salmiya
Country
KUWAITAddress
Shuwaikh 3rd Industrial Area Buildino.61, , Salmiya, , Kuwait
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).
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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 |
|---|---|---|---|
| 3/21/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) | |
| 3/21/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/21/2016 | 54FAT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/21/2016 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Mujezat Al Shifa General Trading Co's FDA import refusal history?
Mujezat Al Shifa General Trading Co (FEI: 3010811895) has 4 FDA import refusal record(s) in our database, spanning from 3/21/2016 to 3/21/2016.
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. Mujezat Al Shifa General Trading Co's FEI number is 3010811895.
What types of violations has Mujezat Al Shifa General Trading Co received?
Mujezat Al Shifa General Trading Co 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 Mujezat Al Shifa General Trading Co come from?
All FDA import refusal data for Mujezat Al Shifa General Trading Co 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.