Yusra Luza
⚠️ Moderate Risk
FEI: 3009112758 • Dubai, Dubai • UNITED ARAB EMIRATES
FEI Number
3009112758
Location
Dubai, Dubai
Country
UNITED ARAB EMIRATESAddress
Al Ras Rd, , Dubai, 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
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New Orleans District Office (NOL-DO) | |
| 7/11/2016 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New Orleans District Office (NOL-DO) | |
| 6/26/2015 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 8/31/2012 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 8/31/2012 | 53BY99OTHER BATH PREPARATIONS, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/12/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 6/12/2012 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New Orleans District Office (NOL-DO) | |
| 6/12/2012 | 66YDJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Yusra Luza's FDA import refusal history?
Yusra Luza (FEI: 3009112758) has 8 FDA import refusal record(s) in our database, spanning from 6/12/2012 to 7/11/2016.
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. Yusra Luza's FEI number is 3009112758.
What types of violations has Yusra Luza received?
Yusra Luza has been cited for 6 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 Yusra Luza come from?
All FDA import refusal data for Yusra Luza 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.