ImportRefusal LogoImportRefusal

Ascal Laboratories New Zealand Ltd.

⚠️ Moderate Risk

FEI: 3004126716 • Auckland • NEW ZEALAND

FEI

FEI Number

3004126716

📍

Location

Auckland

🇳🇿
🏢

Address

1/29 Princes Street, , One Hunga, 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
8/6/2003
Latest Refusal
8/6/2003
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
8/6/2003
66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
8/6/2003
66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Ascal Laboratories New Zealand Ltd.'s FDA import refusal history?

Ascal Laboratories New Zealand Ltd. (FEI: 3004126716) has 2 FDA import refusal record(s) in our database, spanning from 8/6/2003 to 8/6/2003.

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. Ascal Laboratories New Zealand Ltd.'s FEI number is 3004126716.

What types of violations has Ascal Laboratories New Zealand Ltd. received?

Ascal Laboratories 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 Ascal Laboratories New Zealand Ltd. come from?

All FDA import refusal data for Ascal Laboratories 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.