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Pfizer Pharmaceuticals

⚠️ Moderate Risk

FEI: 3008841867 • Henrico, VA • UNITED STATES

FEI

FEI Number

3008841867

📍

Location

Henrico, VA

🇺🇸
🏢

Address

Plant B, 2248 Darbytown Rd, Henrico, VA, United States

Moderate Risk

FDA Import Risk Assessment

42.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/30/2012
Latest Refusal
9/22/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
12.5×10%
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

752×

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
4/30/2012
61NCB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/22/2010
62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Pfizer Pharmaceuticals's FDA import refusal history?

Pfizer Pharmaceuticals (FEI: 3008841867) has 2 FDA import refusal record(s) in our database, spanning from 9/22/2010 to 4/30/2012.

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. Pfizer Pharmaceuticals's FEI number is 3008841867.

What types of violations has Pfizer Pharmaceuticals received?

Pfizer Pharmaceuticals 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 Pharmaceuticals come from?

All FDA import refusal data for Pfizer Pharmaceuticals 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.