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Lab Pharma Venezuela

⚠️ Moderate Risk

FEI: 3005106102 • Caracas • VENEZUELA

FEI

FEI Number

3005106102

📍

Location

Caracas

🇻🇪

Country

VENEZUELA
🏢

Address

Volencia Vzla Eda Paprmo, , Caracas, , Venezuela

Moderate Risk

FDA Import Risk Assessment

43.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
3/6/2008
Latest Refusal
9/6/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
12.0×10%
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

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
3/6/2008
62OCB37IRBESARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/28/2005
61HCE32NITROFURANTOIN (ANTI-BACTERIAL)
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/6/2005
62KDA08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Lab Pharma Venezuela's FDA import refusal history?

Lab Pharma Venezuela (FEI: 3005106102) has 3 FDA import refusal record(s) in our database, spanning from 9/6/2005 to 3/6/2008.

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. Lab Pharma Venezuela's FEI number is 3005106102.

What types of violations has Lab Pharma Venezuela received?

Lab Pharma Venezuela 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 Lab Pharma Venezuela come from?

All FDA import refusal data for Lab Pharma Venezuela 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.