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Prosperity Drugs Pvt. Ltd

⚠️ High Risk

FEI: 3021491587 • Distt. Solan, 1 • INDIA

FEI

FEI Number

3021491587

📍

Location

Distt. Solan, 1

🇮🇳

Country

INDIA
🏢

Address

Village - Belikhol, Baddi a?? Nalagarh Road, , Distt. Solan, 174101, India

High Risk

FDA Import Risk Assessment

65.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

3
Total Refusals
1
Unique Violations
11/17/2025
Latest Refusal
3/4/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
96.7×20%
Frequency
30.0×10%
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

753×

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
11/17/2025
61XDY45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/3/2025
56YDY99ANTIBIOTIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/4/2025
56BDY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Prosperity Drugs Pvt. Ltd's FDA import refusal history?

Prosperity Drugs Pvt. Ltd (FEI: 3021491587) has 3 FDA import refusal record(s) in our database, spanning from 3/4/2025 to 11/17/2025.

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. Prosperity Drugs Pvt. Ltd's FEI number is 3021491587.

What types of violations has Prosperity Drugs Pvt. Ltd received?

Prosperity Drugs 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 Prosperity Drugs Pvt. Ltd come from?

All FDA import refusal data for Prosperity Drugs 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.