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AstraZeneca Pharmaceuticals LP

⚠️ Moderate Risk

FEI: 1000198729 • Gaithersburg, MD • UNITED STATES

FEI

FEI Number

1000198729

📍

Location

Gaithersburg, MD

🇺🇸
🏢

Address

1 Medimmune Way, , Gaithersburg, MD, United States

Moderate Risk

FDA Import Risk Assessment

42.7
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
2
Unique Violations
11/5/2012
Latest Refusal
12/16/2011
Earliest Refusal

Score Breakdown

Violation Severity
82.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
11/5/2012
66VIP99MISCELLANEOUS PATENT MEDICINES, ETC.
223FALSE
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/16/2011
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/16/2011
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is AstraZeneca Pharmaceuticals LP's FDA import refusal history?

AstraZeneca Pharmaceuticals LP (FEI: 1000198729) has 3 FDA import refusal record(s) in our database, spanning from 12/16/2011 to 11/5/2012.

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 1000198729.

What types of violations has AstraZeneca Pharmaceuticals LP received?

AstraZeneca Pharmaceuticals LP 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 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.