AstraZeneca Pharmaceuticals LP
⚠️ Moderate Risk
FEI: 2518137 • Wilmington, DE • UNITED STATES
FEI Number
2518137
Location
Wilmington, DE
Country
UNITED STATESAddress
1800 Concord Pike, , Wilmington, DE, United States
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/24/2020 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/8/2020 | 61PDY70DAPAGLIFLOZIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/21/2017 | 61JCA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2017 | 62CDE99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/3/2016 | 60SDA99ANTACID, N.E.C. | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 9/30/2016 | 61PCP99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/4/2012 | 63EDA13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/28/2011 | 61ECQ04BUDESONIDE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/17/2011 | 62ODA32FELODIPINE (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | Florida District Office (FLA-DO) |
| 10/17/2011 | 62CDA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/8/2010 | 60QCL84PROPOFOL (ANESTHETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/14/2010 | 62OCA19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/20/2009 | 62CCA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/21/2008 | 61JDB16ROSUVASTATIN CALCIUM | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/28/2005 | 61UCB05TAMOXIFEN CITRATE (ANTI-ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 62TCC06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 5/23/2002 | 64RCB17ANASTROZOLE (HORMONE) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is AstraZeneca Pharmaceuticals LP's FDA import refusal history?
AstraZeneca Pharmaceuticals LP (FEI: 2518137) has 17 FDA import refusal record(s) in our database, spanning from 5/23/2002 to 11/24/2020.
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 Pharmaceuticals LP's FEI number is 2518137.
What types of violations has AstraZeneca Pharmaceuticals LP received?
AstraZeneca Pharmaceuticals LP has been cited for 3 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 Pharmaceuticals LP come from?
All FDA import refusal data for AstraZeneca Pharmaceuticals LP 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.