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FRESENIUS MEDICAL CARE CANADA INC.

⚠️ Moderate Risk

FEI: 3007615444 • Richmond Hill, Ontario • CANADA

FEI

FEI Number

3007615444

📍

Location

Richmond Hill, Ontario

🇨🇦

Country

CANADA
🏢

Address

45 Staples Ave Suite 110, , Richmond Hill, 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
3/20/2019
Latest Refusal
3/20/2019
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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
3/20/2019
78FLAMONITOR, TEMPERATURE, DIALYSIS
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FRESENIUS MEDICAL CARE CANADA INC.'s FDA import refusal history?

FRESENIUS MEDICAL CARE CANADA INC. (FEI: 3007615444) has 1 FDA import refusal record(s) in our database, spanning from 3/20/2019 to 3/20/2019.

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. FRESENIUS MEDICAL CARE CANADA INC.'s FEI number is 3007615444.

What types of violations has FRESENIUS MEDICAL CARE CANADA INC. received?

FRESENIUS MEDICAL CARE CANADA 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 FRESENIUS MEDICAL CARE CANADA INC. come from?

All FDA import refusal data for FRESENIUS MEDICAL CARE CANADA 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.