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ARNA Pharma Pty., Ltd.

⚠️ Moderate Risk

FEI: 3007428662 • Frenchs Forest, New South Wales • AUSTRALIA

FEI

FEI Number

3007428662

📍

Location

Frenchs Forest, New South Wales

🇦🇺

Country

AUSTRALIA
🏢

Address

20 Rodborough Road, , Frenchs Forest, New South Wales, Australia

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/17/2013
Latest Refusal
9/17/2013
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
9/17/2013
63XIE83MANNITOL (DIAGNOSTIC AID) (DRUGS)
27DRUG GMPS
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is ARNA Pharma Pty., Ltd.'s FDA import refusal history?

ARNA Pharma Pty., Ltd. (FEI: 3007428662) has 1 FDA import refusal record(s) in our database, spanning from 9/17/2013 to 9/17/2013.

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. ARNA Pharma Pty., Ltd.'s FEI number is 3007428662.

What types of violations has ARNA Pharma Pty., Ltd. received?

ARNA Pharma 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 ARNA Pharma Pty., Ltd. come from?

All FDA import refusal data for ARNA Pharma 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.