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ASTRA ZENECA PHARMA INDIA LTD

⚠️ Moderate Risk

FEI: 3013467925 • Bangalore, Karnataka • INDIA

FEI

FEI Number

3013467925

📍

Location

Bangalore, Karnataka

🇮🇳

Country

INDIA
🏢

Address

12 Mile Bellan Rd, , Bangalore, Karnataka, India

Moderate Risk

FDA Import Risk Assessment

40.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/29/2021
Latest Refusal
9/29/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.3×20%
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
9/29/2021
60QCY67LIDOCAINE (ANESTHETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ASTRA ZENECA PHARMA INDIA LTD's FDA import refusal history?

ASTRA ZENECA PHARMA INDIA LTD (FEI: 3013467925) has 1 FDA import refusal record(s) in our database, spanning from 9/29/2021 to 9/29/2021.

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. ASTRA ZENECA PHARMA INDIA LTD's FEI number is 3013467925.

What types of violations has ASTRA ZENECA PHARMA INDIA LTD received?

ASTRA ZENECA PHARMA INDIA 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 ASTRA ZENECA PHARMA INDIA LTD come from?

All FDA import refusal data for ASTRA ZENECA PHARMA INDIA 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.