Astrazeneca, S.A. De C.V.
⚠️ High Risk
FEI: 3003596046 • Naucalpan de Juarez, Mexico • MEXICO
FEI Number
3003596046
Location
Naucalpan de Juarez, Mexico
Country
MEXICOAddress
Avenida Super Avenida Lomas Verdes 67, Fracc. LOMAS VERDES, Naucalpan de Juarez, Mexico, Mexico
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/17/2024 | 63ECY13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/7/2023 | 62TDY06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/19/2012 | 62KCB10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/7/2012 | 79MCZSUTURE REMOVAL KIT | San Francisco District Office (SAN-DO) | |
| 11/4/2009 | 62OBP19CANDESARTAN CILEXETIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/4/2009 | 63HAN10LACTULOSE (CATHARTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/24/2009 | 60XCB17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/29/2006 | 62KDB10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/13/2002 | 65KCK08LATANOPROST (PROSTAGLANDIN) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Astrazeneca, S.A. De C.V.'s FDA import refusal history?
Astrazeneca, S.A. De C.V. (FEI: 3003596046) has 9 FDA import refusal record(s) in our database, spanning from 6/13/2002 to 5/17/2024.
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.A. De C.V.'s FEI number is 3003596046.
What types of violations has Astrazeneca, S.A. De C.V. received?
Astrazeneca, S.A. De C.V. has been cited for 5 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, S.A. De C.V. come from?
All FDA import refusal data for Astrazeneca, S.A. De C.V. 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.