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Roopa

⚠️ Moderate Risk

FEI: 3011529646 • Bangalorebangalore • INDIA

FEI

FEI Number

3011529646

📍

Location

Bangalorebangalore

🇮🇳

Country

INDIA
🏢

Address

No.2,Elegency Apt Rajarajeswari Layout, , Bangalorebangalore, , India

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
5/22/2015
Latest Refusal
5/22/2015
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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

DateProductViolationsDivision
5/22/2015
61TCY31DOMPERIDONE
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Roopa's FDA import refusal history?

Roopa (FEI: 3011529646) has 1 FDA import refusal record(s) in our database, spanning from 5/22/2015 to 5/22/2015.

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. Roopa's FEI number is 3011529646.

What types of violations has Roopa received?

Roopa has been cited for 1 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 Roopa come from?

All FDA import refusal data for Roopa 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.