Astra Zeneca
⚠️ Moderate Risk
FEI: 3003649680 • Paranabme • PHILIPPINES
FEI Number
3003649680
Location
Paranabme
Country
PHILIPPINESAddress
Unknown Street, , Paranabme, , Philippines
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).
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).
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 |
|---|---|---|---|
| 7/25/2005 | 62CDB99ANTI-HYPERTENSIVE N.E.C. | Detroit District Office (DET-DO) | |
| 8/30/2002 | 63XAY99DIAGOSTIC AID (DRUGS) N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/29/2002 | 62OCY22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Astra Zeneca's FDA import refusal history?
Astra Zeneca (FEI: 3003649680) has 3 FDA import refusal record(s) in our database, spanning from 8/29/2002 to 7/25/2005.
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. Astra Zeneca's FEI number is 3003649680.
What types of violations has Astra Zeneca received?
Astra Zeneca has been cited for 4 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 Astra Zeneca come from?
All FDA import refusal data for Astra Zeneca 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.