REVE PHARMA
⚠️ Moderate Risk
FEI: 3010162437 • Sinnar, Maharashtra • INDIA
FEI Number
3010162437
Location
Sinnar, Maharashtra
Country
INDIAAddress
Plot No: 78, STICE, Musalgaon M.I.D.C, Sinnar, Maharashtra, India
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
Frequently Asked Questions
What is REVE PHARMA's FDA import refusal history?
REVE PHARMA (FEI: 3010162437) has 1 FDA import refusal record(s) in our database, spanning from 9/24/2013 to 9/24/2013.
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. REVE PHARMA's FEI number is 3010162437.
What types of violations has REVE PHARMA received?
REVE PHARMA 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 REVE PHARMA come from?
All FDA import refusal data for REVE PHARMA 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.