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Hospira Australia Pty Ltd.

⚠️ Moderate Risk

FEI: 3001174929 • Mulgrave, Victoria • AUSTRALIA

FEI

FEI Number

3001174929

📍

Location

Mulgrave, Victoria

🇦🇺

Country

AUSTRALIA
🏢

Address

1-39 Lexia Pl, , Mulgrave, Victoria, 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
8/24/2011
Latest Refusal
8/24/2011
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
8/24/2011
62HCZ99ANTI-MICROBIAL N.E.C.
27DRUG GMPS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Hospira Australia Pty Ltd.'s FDA import refusal history?

Hospira Australia Pty Ltd. (FEI: 3001174929) has 1 FDA import refusal record(s) in our database, spanning from 8/24/2011 to 8/24/2011.

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. Hospira Australia Pty Ltd.'s FEI number is 3001174929.

What types of violations has Hospira Australia Pty Ltd. received?

Hospira 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 Hospira Australia Pty Ltd. come from?

All FDA import refusal data for Hospira 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.