ASTRAZENCA PHARMA INDIA PVT LTD
⚠️ High Risk
FEI: 3017190135 • Bangalore, Karnataka • INDIA
FEI Number
3017190135
Location
Bangalore, Karnataka
Country
INDIAAddress
Survey No 5-2/E 12th Mile Belley Road, , Bangalore, Karnataka, India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
Frequently Asked Questions
What is ASTRAZENCA PHARMA INDIA PVT LTD's FDA import refusal history?
ASTRAZENCA PHARMA INDIA PVT LTD (FEI: 3017190135) has 2 FDA import refusal record(s) in our database, spanning from 4/27/2022 to 3/26/2025.
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. ASTRAZENCA PHARMA INDIA PVT LTD's FEI number is 3017190135.
What types of violations has ASTRAZENCA PHARMA INDIA PVT LTD received?
ASTRAZENCA PHARMA INDIA PVT LTD has been cited for 2 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 ASTRAZENCA PHARMA INDIA PVT LTD come from?
All FDA import refusal data for ASTRAZENCA PHARMA INDIA 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.