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Sulzer Microflow Inc

⚠️ Moderate Risk

FEI: 3003918256 • Richmond, BC • CANADA

FEI

FEI Number

3003918256

📍

Location

Richmond, BC

🇨🇦

Country

CANADA
🏢

Address

1-11220 Voyageur Way, , Richmond, BC, Canada

Moderate Risk

FDA Import Risk Assessment

41.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
6/21/2002
Latest Refusal
6/12/2002
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2373×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
6/21/2002
74DYEHEART-VALVE, REPLACEMENT
237NO PMA
New Orleans District Office (NOL-DO)
6/13/2002
87MOOORTHOPEDIC IMPLANT MATERIAL
237NO PMA
New Orleans District Office (NOL-DO)
6/12/2002
74DYEHEART-VALVE, REPLACEMENT
237NO PMA
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sulzer Microflow Inc's FDA import refusal history?

Sulzer Microflow Inc (FEI: 3003918256) has 3 FDA import refusal record(s) in our database, spanning from 6/12/2002 to 6/21/2002.

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. Sulzer Microflow Inc's FEI number is 3003918256.

What types of violations has Sulzer Microflow Inc received?

Sulzer Microflow 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 Sulzer Microflow Inc come from?

All FDA import refusal data for Sulzer Microflow 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.