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Astellas Pharma US Inc.

⚠️ Moderate Risk

FEI: 1000036852 • Northbrook, IL • UNITED STATES

FEI

FEI Number

1000036852

📍

Location

Northbrook, IL

🇺🇸
🏢

Address

2375 Waterview Dr, , Northbrook, IL, United States

Moderate Risk

FDA Import Risk Assessment

43.1
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
7/17/2019
Latest Refusal
6/15/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
4.2×10%
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).

Refusal History

DateProductViolationsDivision
7/17/2019
61KDB72SOLIFENACIN SUCCINATE (ANTI-CHOLINERGIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/17/2019
60CDB99ADRENERGIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
6/15/2012
64TCO08TACROLIMUS (IMMUNOSUPPRESSIVE)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Astellas Pharma US Inc.'s FDA import refusal history?

Astellas Pharma US Inc. (FEI: 1000036852) has 3 FDA import refusal record(s) in our database, spanning from 6/15/2012 to 7/17/2019.

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. Astellas Pharma US Inc.'s FEI number is 1000036852.

What types of violations has Astellas Pharma US Inc. received?

Astellas Pharma US Inc. 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 Astellas Pharma US Inc. come from?

All FDA import refusal data for Astellas Pharma US Inc. 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.