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PURE AND CURE HEALTH CARE PVT LT

⚠️ High Risk

FEI: 3030153231 • Ranipur Haridwar • INDIA

FEI

FEI Number

3030153231

📍

Location

Ranipur Haridwar

🇮🇳

Country

INDIA
🏢

Address

26 A Sector Iie Sidcul, , Ranipur Haridwar, , India

High Risk

FDA Import Risk Assessment

60.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/18/2025
Latest Refusal
12/18/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
98.6×20%
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
12/18/2025
61EDA09MONTELUKAST SODIUM (ANTI-ASTHMATIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PURE AND CURE HEALTH CARE PVT LT's FDA import refusal history?

PURE AND CURE HEALTH CARE PVT LT (FEI: 3030153231) has 1 FDA import refusal record(s) in our database, spanning from 12/18/2025 to 12/18/2025.

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. PURE AND CURE HEALTH CARE PVT LT's FEI number is 3030153231.

What types of violations has PURE AND CURE HEALTH CARE PVT LT received?

PURE AND CURE HEALTH CARE PVT LT 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 PURE AND CURE HEALTH CARE PVT LT come from?

All FDA import refusal data for PURE AND CURE HEALTH CARE PVT LT 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.