ImportRefusal LogoImportRefusal

Novartis Health Care Pvt Ltd.

⚠️ Moderate Risk

FEI: 3008313478 • Kopar Puma • INDIA

FEI

FEI Number

3008313478

📍

Location

Kopar Puma

🇮🇳

Country

INDIA
🏢

Address

Gala No 1a/2a Bldg 28, , Kopar Puma, , India

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/19/2012
Latest Refusal
6/19/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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
6/19/2012
62ADL05ZOLEDRONIC ACID
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Novartis Health Care Pvt Ltd.'s FDA import refusal history?

Novartis Health Care Pvt Ltd. (FEI: 3008313478) has 1 FDA import refusal record(s) in our database, spanning from 6/19/2012 to 6/19/2012.

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. Novartis Health Care Pvt Ltd.'s FEI number is 3008313478.

What types of violations has Novartis Health Care Pvt Ltd. received?

Novartis Health Care 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 Novartis Health Care Pvt Ltd. come from?

All FDA import refusal data for Novartis Health Care 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.