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Pfizer

⚠️ Moderate Risk

FEI: 3003967026 • Valencia • VENEZUELA

FEI

FEI Number

3003967026

📍

Location

Valencia

🇻🇪

Country

VENEZUELA
🏢

Address

Av Henry Ford Zona Ind, , Valencia, , Venezuela

Moderate Risk

FDA Import Risk Assessment

42.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
6/20/2012
Latest Refusal
1/6/2005
Earliest Refusal

Score Breakdown

Violation Severity
83.3×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
6.7×10%
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

755×

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).

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
6/20/2012
61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/20/2012
56BCE03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/16/2006
61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/6/2005
62UCK14LEVOPROPOXYPHENE NAPSYLATE (ANTI-TUSSIVE/COLD)
75UNAPPROVED
New Orleans District Office (NOL-DO)
1/6/2005
61WCA45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
118NOT LISTED
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pfizer's FDA import refusal history?

Pfizer (FEI: 3003967026) has 5 FDA import refusal record(s) in our database, spanning from 1/6/2005 to 6/20/2012.

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's FEI number is 3003967026.

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.