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CENTER FOR PAIN AND STRESS RESEARCH, LTD.

✅ Low Risk

FEI: 3002669614 • Etobicoke, Ontario • CANADA

FEI

FEI Number

3002669614

📍

Location

Etobicoke, Ontario

🇨🇦

Country

CANADA
🏢

Address

Etobicoke, , Etobicoke, Ontario, Canada

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
5/17/2007
Latest Refusal
5/17/2007
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
5/17/2007
84GZJSTIMULATOR, NERVE, TRANSCUTANEOUS, FOR PAIN RELIEF
341REGISTERED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is CENTER FOR PAIN AND STRESS RESEARCH, LTD.'s FDA import refusal history?

CENTER FOR PAIN AND STRESS RESEARCH, LTD. (FEI: 3002669614) has 1 FDA import refusal record(s) in our database, spanning from 5/17/2007 to 5/17/2007.

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. CENTER FOR PAIN AND STRESS RESEARCH, LTD.'s FEI number is 3002669614.

What types of violations has CENTER FOR PAIN AND STRESS RESEARCH, LTD. received?

CENTER FOR PAIN AND STRESS RESEARCH, LTD. 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 CENTER FOR PAIN AND STRESS RESEARCH, LTD. come from?

All FDA import refusal data for CENTER FOR PAIN AND STRESS RESEARCH, LTD. 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.