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Fisher & Paykel Healthcare Pty. Ltd

⚠️ Moderate Risk

FEI: 10739 • Auckland • NEW ZEALAND

FEI

FEI Number

10739

📍

Location

Auckland

🇳🇿
🏢

Address

25-31 Carbine Rd, Box 14348, Auckland, , New Zealand

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
10/1/2002
Latest Refusal
10/1/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
10/1/2002
80FLKTHERMOMETER, CLINICAL MERCURY
118NOT LISTED
New Orleans District Office (NOL-DO)
10/1/2002
80LDQDEVICE, GENERAL MEDICAL
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Fisher & Paykel Healthcare Pty. Ltd's FDA import refusal history?

Fisher & Paykel Healthcare Pty. Ltd (FEI: 10739) has 2 FDA import refusal record(s) in our database, spanning from 10/1/2002 to 10/1/2002.

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. Fisher & Paykel Healthcare Pty. Ltd's FEI number is 10739.

What types of violations has Fisher & Paykel Healthcare Pty. Ltd received?

Fisher & Paykel Healthcare Pty. 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 Fisher & Paykel Healthcare Pty. Ltd come from?

All FDA import refusal data for Fisher & Paykel Healthcare Pty. 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.