ASTRAZENECA PHARMA INDIA LTD
⚠️ Moderate Risk
FEI: 3014701459 • Bangalore, Karnataka • INDIA
FEI Number
3014701459
Location
Bangalore, Karnataka
Country
INDIAAddress
Block N1, 12th Floor, Bangalore, Karnataka, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2021 | 61PCY70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2020 | 60LCA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 61UCY05TAMOXIFEN CITRATE (ANTI-ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/31/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ASTRAZENECA PHARMA INDIA LTD's FDA import refusal history?
ASTRAZENECA PHARMA INDIA LTD (FEI: 3014701459) has 4 FDA import refusal record(s) in our database, spanning from 8/31/2020 to 12/20/2021.
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. ASTRAZENECA PHARMA INDIA LTD's FEI number is 3014701459.
What types of violations has ASTRAZENECA PHARMA INDIA LTD received?
ASTRAZENECA 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 ASTRAZENECA PHARMA INDIA LTD come from?
All FDA import refusal data for ASTRAZENECA 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.