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South Pacific Sera Limited

⚠️ Moderate Risk

FEI: 3001765316 • Timaru • NEW ZEALAND

FEI

FEI Number

3001765316

📍

Location

Timaru

🇳🇿
🏢

Address

26 Kennels Road, R D 4, Timaru, , New Zealand

Moderate Risk

FDA Import Risk Assessment

30.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/3/2023
Latest Refusal
3/3/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
28.8×20%
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

1181×

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
3/3/2023
66ACS01HYALURONIDASE (FOR INJECTIONS) (SPREADING AGENT)
118NOT LISTED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is South Pacific Sera Limited's FDA import refusal history?

South Pacific Sera Limited (FEI: 3001765316) has 1 FDA import refusal record(s) in our database, spanning from 3/3/2023 to 3/3/2023.

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. South Pacific Sera Limited's FEI number is 3001765316.

What types of violations has South Pacific Sera Limited received?

South Pacific Sera Limited 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 South Pacific Sera Limited come from?

All FDA import refusal data for South Pacific Sera Limited 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.