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Pfizer

✅ Low Risk

FEI: 3004847397 • Trenton, NJ • UNITED STATES

FEI

FEI Number

3004847397

📍

Location

Trenton, NJ

🇺🇸
🏢

Address

1001 Jack Stephan Way, , Trenton, NJ, United States

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
1/7/2005
Latest Refusal
1/7/2005
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

1791×

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.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
1/7/2005
65PCB02SILDENAFIL CITRATE (REGULATOR)
179AGR RX
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pfizer's FDA import refusal history?

Pfizer (FEI: 3004847397) has 1 FDA import refusal record(s) in our database, spanning from 1/7/2005 to 1/7/2005.

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. Pfizer's FEI number is 3004847397.

What types of violations has Pfizer received?

Pfizer 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 Pfizer come from?

All FDA import refusal data for Pfizer 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.