Rt Magique
⚠️ Moderate Risk
FEI: 3008907503 • Chaparaco Michoacan • MEXICO
FEI Number
3008907503
Location
Chaparaco Michoacan
Country
MEXICOAddress
Jose Maria Morelos 40, , Chaparaco Michoacan, , Mexico
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2012 | 66PBL10SULISOBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | Cincinnati District Office (CIN-DO) | |
| 8/15/2012 | 66PBL10SULISOBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | Cincinnati District Office (CIN-DO) | |
| 8/15/2012 | 66PBL10SULISOBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Rt Magique's FDA import refusal history?
Rt Magique (FEI: 3008907503) has 3 FDA import refusal record(s) in our database, spanning from 8/15/2012 to 10/16/2012.
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. Rt Magique's FEI number is 3008907503.
What types of violations has Rt Magique received?
Rt Magique has been cited for 2 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 Rt Magique come from?
All FDA import refusal data for Rt Magique 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.