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McW Healthcare Private Ltd.

⚠️ Moderate Risk

FEI: 3012899888 • Indore, Madhya Pradesh • INDIA

FEI

FEI Number

3012899888

📍

Location

Indore, Madhya Pradesh

🇮🇳

Country

INDIA
🏢

Address

286 287a 287b Sector-E Industrial Area,, Sanwer Road, Indore, Madhya Pradesh, India

Moderate Risk

FDA Import Risk Assessment

42.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/3/2018
Latest Refusal
11/4/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
12.1×10%
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

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
7/3/2018
62LCA99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/4/2016
61FCA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is McW Healthcare Private Ltd.'s FDA import refusal history?

McW Healthcare Private Ltd. (FEI: 3012899888) has 2 FDA import refusal record(s) in our database, spanning from 11/4/2016 to 7/3/2018.

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. McW Healthcare Private Ltd.'s FEI number is 3012899888.

What types of violations has McW Healthcare Private Ltd. received?

McW Healthcare Private 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 McW Healthcare Private Ltd. come from?

All FDA import refusal data for McW Healthcare Private 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.