ASTRAZENECA
⚠️ Moderate Risk
FEI: 3012857386 • Naucalpan De Juarez, Mexico • MEXICO
FEI Number
3012857386
Location
Naucalpan De Juarez, Mexico
Country
MEXICOAddress
Verdes 67 Lomas Verdes, Zona Industrial Naucalpan, Naucalpan De Juarez, Naucalpan De Juarez, Mexico, Mexico
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 |
|---|---|---|---|
| 5/18/2015 | 64RAY17ANASTROZOLE (HORMONE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/29/2007 | 66NCA03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/10/2007 | 62OCA19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/10/2007 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/10/2007 | 62ODA32FELODIPINE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is ASTRAZENECA's FDA import refusal history?
ASTRAZENECA (FEI: 3012857386) has 5 FDA import refusal record(s) in our database, spanning from 5/10/2007 to 5/18/2015.
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's FEI number is 3012857386.
What types of violations has ASTRAZENECA received?
ASTRAZENECA 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 come from?
All FDA import refusal data for ASTRAZENECA 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.