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Pls Pacific Laser Systems Llc

⚠️ Moderate Risk

FEI: 3006514159 • San Rafael, CA • UNITED STATES

FEI

FEI Number

3006514159

📍

Location

San Rafael, CA

🇺🇸
🏢

Address

2550 Kerner Blvd, , San Rafael, CA, United States

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/30/2018
Latest Refusal
3/30/2018
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
3/30/2018
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
47NON STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Pls Pacific Laser Systems Llc's FDA import refusal history?

Pls Pacific Laser Systems Llc (FEI: 3006514159) has 1 FDA import refusal record(s) in our database, spanning from 3/30/2018 to 3/30/2018.

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. Pls Pacific Laser Systems Llc's FEI number is 3006514159.

What types of violations has Pls Pacific Laser Systems Llc received?

Pls Pacific Laser Systems 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 Pls Pacific Laser Systems Llc come from?

All FDA import refusal data for Pls Pacific Laser Systems 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.