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Sdl Optics Inc.

⚠️ Moderate Risk

FEI: 3002732871 • Saanichton, BC • CANADA

FEI

FEI Number

3002732871

📍

Location

Saanichton, BC

🇨🇦

Country

CANADA
🏢

Address

Gateway Park, 2261a Kealing Cross Rd, , Saanichton, BC, Canada

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/5/2002
Latest Refusal
2/16/2002
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

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
4/5/2002
95L22LASER PRODUCT FOR NON-MEDICAL USE
476NO REGISTR
New Orleans District Office (NOL-DO)
2/16/2002
95L22LASER PRODUCT FOR NON-MEDICAL USE
126FAILS STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sdl Optics Inc.'s FDA import refusal history?

Sdl Optics Inc. (FEI: 3002732871) has 2 FDA import refusal record(s) in our database, spanning from 2/16/2002 to 4/5/2002.

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. Sdl Optics Inc.'s FEI number is 3002732871.

What types of violations has Sdl Optics Inc. received?

Sdl Optics Inc. 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 Sdl Optics Inc. come from?

All FDA import refusal data for Sdl Optics Inc. 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.