Antipodes New Zealand Limited
⚠️ High Risk
FEI: 3009016660 • Wellington • NEW ZEALAND
FEI Number
3009016660
Location
Wellington
Country
NEW ZEALANDAddress
207 Tasman St, , Wellington, , New Zealand
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/21/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LG03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 9/21/2011 | 53LD07NIGHT (SKIN CARE PREPARATIONS) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Antipodes New Zealand Limited's FDA import refusal history?
Antipodes New Zealand Limited (FEI: 3009016660) has 17 FDA import refusal record(s) in our database, spanning from 9/21/2011 to 9/21/2011.
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. Antipodes New Zealand Limited's FEI number is 3009016660.
What types of violations has Antipodes New Zealand Limited received?
Antipodes New Zealand Limited has been cited for 2 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 Antipodes New Zealand Limited come from?
All FDA import refusal data for Antipodes New Zealand 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.