ImportRefusal LogoImportRefusal

Medreich Limited

⚠️ Moderate Risk

FEI: 3007103842 • Bengaluru, Karnataka • INDIA

FEI

FEI Number

3007103842

📍

Location

Bengaluru, Karnataka

🇮🇳

Country

INDIA
🏢

Address

Avalahalli, 4/3 Anjanapura Post; Kanakapura Road, Bengaluru, Karnataka, India

Moderate Risk

FDA Import Risk Assessment

42.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
6/23/2021
Latest Refusal
1/29/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
8.3×10%
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

752×

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
6/23/2021
60ZCA02ALBENDAZOLE (ANTIPARASITIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/29/2019
62LDA37QUININE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Medreich Limited's FDA import refusal history?

Medreich Limited (FEI: 3007103842) has 2 FDA import refusal record(s) in our database, spanning from 1/29/2019 to 6/23/2021.

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. Medreich Limited's FEI number is 3007103842.

What types of violations has Medreich Limited received?

Medreich Limited 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 Medreich Limited come from?

All FDA import refusal data for Medreich Limited 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.