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Quest Pharmaceuticals (P) Ltd

⚠️ Moderate Risk

FEI: 3007114800 • Kathmandu, Kathmandu • NEPAL

FEI

FEI Number

3007114800

📍

Location

Kathmandu, Kathmandu

🇳🇵

Country

NEPAL
🏢

Address

Chhatapipra, , Kathmandu, Kathmandu, Nepal

Moderate Risk

FDA Import Risk Assessment

44.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
1/28/2019
Latest Refusal
10/12/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
13.1×10%
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
1/28/2019
61PDA55METFORMIN HCL (ANTI-DIABETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/26/2017
62ODC14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/12/2016
62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Quest Pharmaceuticals (P) Ltd's FDA import refusal history?

Quest Pharmaceuticals (P) Ltd (FEI: 3007114800) has 3 FDA import refusal record(s) in our database, spanning from 10/12/2016 to 1/28/2019.

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. Quest Pharmaceuticals (P) Ltd's FEI number is 3007114800.

What types of violations has Quest Pharmaceuticals (P) Ltd received?

Quest Pharmaceuticals (P) 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 Quest Pharmaceuticals (P) Ltd come from?

All FDA import refusal data for Quest Pharmaceuticals (P) 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.