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Boots Healthcare New Zealand Ltd

⚠️ Moderate Risk

FEI: 3006348779 • Wellington1 • NEW ZEALAND

FEI

FEI Number

3006348779

📍

Location

Wellington1

🇳🇿
🏢

Address

Po Box 27 341, , Wellington1, , New Zealand

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/31/2007
Latest Refusal
7/31/2007
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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
7/31/2007
62GDA41IBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Boots Healthcare New Zealand Ltd's FDA import refusal history?

Boots Healthcare New Zealand Ltd (FEI: 3006348779) has 1 FDA import refusal record(s) in our database, spanning from 7/31/2007 to 7/31/2007.

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. Boots Healthcare New Zealand Ltd's FEI number is 3006348779.

What types of violations has Boots Healthcare New Zealand Ltd received?

Boots Healthcare New Zealand 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 Boots Healthcare New Zealand Ltd come from?

All FDA import refusal data for Boots Healthcare New Zealand 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.