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SARINGER LIFE SCIENCE TECHNOLOGIES INC.

⚠️ Moderate Risk

FEI: 3007420698 • Stouffville, Ontario • CANADA

FEI

FEI Number

3007420698

📍

Location

Stouffville, Ontario

🇨🇦

Country

CANADA
🏢

Address

13231 Kennedy Rd, , Stouffville, Ontario, Canada

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
9/17/2012
Latest Refusal
9/17/2012
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

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
9/17/2012
89ISHCOMPONENT, EXTERNAL, LIMB, ANKLE/FOOT
84RX DEVICE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is SARINGER LIFE SCIENCE TECHNOLOGIES INC.'s FDA import refusal history?

SARINGER LIFE SCIENCE TECHNOLOGIES INC. (FEI: 3007420698) has 1 FDA import refusal record(s) in our database, spanning from 9/17/2012 to 9/17/2012.

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. SARINGER LIFE SCIENCE TECHNOLOGIES INC.'s FEI number is 3007420698.

What types of violations has SARINGER LIFE SCIENCE TECHNOLOGIES INC. received?

SARINGER LIFE SCIENCE TECHNOLOGIES INC. 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 SARINGER LIFE SCIENCE TECHNOLOGIES INC. come from?

All FDA import refusal data for SARINGER LIFE SCIENCE TECHNOLOGIES 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.