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Inova Pharmaceuticals (Australia) PTY Ltd

⚠️ Moderate Risk

FEI: 3006361015 • Chatswood, New South Wales • AUSTRALIA

FEI

FEI Number

3006361015

📍

Location

Chatswood, New South Wales

🇦🇺

Country

AUSTRALIA
🏢

Address

10-12 Help St, , Chatswood, New South Wales, Australia

Moderate Risk

FDA Import Risk Assessment

41.9
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
10/17/2009
Latest Refusal
8/31/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
6.4×10%
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

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
10/17/2009
63ECB23FLECAINIDE ACETATE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC))
75UNAPPROVED
New Orleans District Office (NOL-DO)
8/31/2006
60QDL99ANESTHETIC, N.E.C.
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Inova Pharmaceuticals (Australia) PTY Ltd's FDA import refusal history?

Inova Pharmaceuticals (Australia) PTY Ltd (FEI: 3006361015) has 2 FDA import refusal record(s) in our database, spanning from 8/31/2006 to 10/17/2009.

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. Inova Pharmaceuticals (Australia) PTY Ltd's FEI number is 3006361015.

What types of violations has Inova Pharmaceuticals (Australia) PTY Ltd received?

Inova Pharmaceuticals (Australia) 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 Inova Pharmaceuticals (Australia) PTY Ltd come from?

All FDA import refusal data for Inova Pharmaceuticals (Australia) 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.