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Pegasus Farmaco India Pvt Ltd

⚠️ Moderate Risk

FEI: 3010670296 • Ramnagar • INDIA

FEI

FEI Number

3010670296

📍

Location

Ramnagar

🇮🇳

Country

INDIA
🏢

Address

Kashipur Road, Village Tanda Mallu, , Ramnagar, , 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
11/25/2014
Latest Refusal
11/25/2014
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
11/25/2014
62TCA07PANTOPRAZOLE SODIUM
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Pegasus Farmaco India Pvt Ltd's FDA import refusal history?

Pegasus Farmaco India Pvt Ltd (FEI: 3010670296) has 1 FDA import refusal record(s) in our database, spanning from 11/25/2014 to 11/25/2014.

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. Pegasus Farmaco India Pvt Ltd's FEI number is 3010670296.

What types of violations has Pegasus Farmaco India Pvt Ltd received?

Pegasus Farmaco India Pvt Ltd 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 Pegasus Farmaco India Pvt Ltd come from?

All FDA import refusal data for Pegasus Farmaco India Pvt Ltd 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.