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Vigel

⚠️ Moderate Risk

FEI: 3005259090 • Van Nuys, CA • UNITED STATES

FEI

FEI Number

3005259090

📍

Location

Van Nuys, CA

🇺🇸
🏢

Address

8025 Haskell Ave, , Van Nuys, CA, United States

Moderate Risk

FDA Import Risk Assessment

29.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/21/2008
Latest Refusal
11/21/2008
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

2232×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
11/21/2008
80KMJLUBRICANT, PATIENT
118NOT LISTED
223FALSE
Los Angeles District Office (LOS-DO)
11/21/2008
80KMJLUBRICANT, PATIENT
118NOT LISTED
223FALSE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Vigel's FDA import refusal history?

Vigel (FEI: 3005259090) has 2 FDA import refusal record(s) in our database, spanning from 11/21/2008 to 11/21/2008.

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. Vigel's FEI number is 3005259090.

What types of violations has Vigel received?

Vigel 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 Vigel come from?

All FDA import refusal data for Vigel 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.