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Biznet C.A.

⚠️ Moderate Risk

FEI: 3003462429 • Caracas, D.F. • VENEZUELA

FEI

FEI Number

3003462429

📍

Location

Caracas, D.F.

🇻🇪

Country

VENEZUELA
🏢

Address

Sante Fe Local C3 68 Sta Fe, , Caracas, D.F., Venezuela

Moderate Risk

FDA Import Risk Assessment

37.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
1/7/2012
Latest Refusal
11/16/2001
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
2.0×10%
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).

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
1/7/2012
63NAB23ACETYLCHOLINE CHLORIDE (CHOLINERGIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)
11/16/2001
86LPLLENSES, SOFT CONTACT, DAILY WEAR
84RX DEVICE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Biznet C.A.'s FDA import refusal history?

Biznet C.A. (FEI: 3003462429) has 2 FDA import refusal record(s) in our database, spanning from 11/16/2001 to 1/7/2012.

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. Biznet C.A.'s FEI number is 3003462429.

What types of violations has Biznet C.A. received?

Biznet C.A. 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 Biznet C.A. come from?

All FDA import refusal data for Biznet C.A. 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.