Revlon Intl Inc
⚠️ Moderate Risk
FEI: 3001869587 • New York, NY • UNITED STATES
FEI Number
3001869587
Location
New York, NY
Country
UNITED STATESAddress
625 Madison Ave, , New York, NY, United States
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.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2014 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 9/18/2014 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 9/18/2014 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) | |
| 9/18/2014 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Revlon Intl Inc's FDA import refusal history?
Revlon Intl Inc (FEI: 3001869587) has 4 FDA import refusal record(s) in our database, spanning from 9/18/2014 to 9/18/2014.
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. Revlon Intl Inc's FEI number is 3001869587.
What types of violations has Revlon Intl Inc received?
Revlon Intl Inc has been cited for 5 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 Revlon Intl Inc come from?
All FDA import refusal data for Revlon Intl Inc 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.