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Pfizer Global Supply Japan Inc.

⚠️ Moderate Risk

FEI: 3002807870 • Chita-Gun, Aichi • JAPAN

FEI

FEI Number

3002807870

📍

Location

Chita-Gun, Aichi

🇯🇵

Country

JAPAN
🏢

Address

2-Gogochi, Taketoyo-cho, , Chita-Gun, Aichi, Japan

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/19/2004
Latest Refusal
11/19/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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
11/19/2004
62GCB88CARPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pfizer Global Supply Japan Inc.'s FDA import refusal history?

Pfizer Global Supply Japan Inc. (FEI: 3002807870) has 1 FDA import refusal record(s) in our database, spanning from 11/19/2004 to 11/19/2004.

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. Pfizer Global Supply Japan Inc.'s FEI number is 3002807870.

What types of violations has Pfizer Global Supply Japan Inc. received?

Pfizer Global Supply Japan 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 Pfizer Global Supply Japan Inc. come from?

All FDA import refusal data for Pfizer Global Supply Japan 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.