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3 Gen, Llc

⚠️ Moderate Risk

FEI: 3008233122 • San Juan Capistrano, CA • UNITED STATES

FEI

FEI Number

3008233122

📍

Location

San Juan Capistrano, CA

🇺🇸
🏢

Address

31521 Rancho Viejo Rd., , San Juan Capistrano, CA, United States

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/22/2013
Latest Refusal
1/22/2013
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
1/22/2013
90LLZSYSTEM, IMAGE PROCESSING
237NO PMA
Detroit District Office (DET-DO)

Frequently Asked Questions

What is 3 Gen, Llc's FDA import refusal history?

3 Gen, Llc (FEI: 3008233122) has 1 FDA import refusal record(s) in our database, spanning from 1/22/2013 to 1/22/2013.

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. 3 Gen, Llc's FEI number is 3008233122.

What types of violations has 3 Gen, Llc received?

3 Gen, Llc 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 3 Gen, Llc come from?

All FDA import refusal data for 3 Gen, Llc 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.