ImportRefusal LogoImportRefusal

Prolinx Labs Corp

⚠️ Moderate Risk

FEI: 3001163328 • San Jose, CA • UNITED STATES

FEI

FEI Number

3001163328

📍

Location

San Jose, CA

🇺🇸
🏢

Address

90 Great Oaks Blvd Ste 107, , San Jose, CA, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/9/2019
Latest Refusal
9/9/2019
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
9/9/2019
76EJFBRACKET, METAL, ORTHODONTIC
476NO REGISTR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Prolinx Labs Corp's FDA import refusal history?

Prolinx Labs Corp (FEI: 3001163328) has 1 FDA import refusal record(s) in our database, spanning from 9/9/2019 to 9/9/2019.

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. Prolinx Labs Corp's FEI number is 3001163328.

What types of violations has Prolinx Labs Corp received?

Prolinx Labs Corp 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 Prolinx Labs Corp come from?

All FDA import refusal data for Prolinx Labs Corp 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.