Shop New Zealand
⚠️ Moderate Risk
FEI: 3005724881 • Auckland • NEW ZEALAND
FEI Number
3005724881
Location
Auckland
Country
NEW ZEALANDAddress
Po Box 5348 Wellesley St, , Auckland, , New Zealand
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/30/2006 | 36CHY04HONEY | 488HEALTH C | New Orleans District Office (NOL-DO) |
| 10/30/2006 | 53CC04EYE LOTION (EYE MAKEUP PREPARATIONS) | New Orleans District Office (NOL-DO) | |
| 10/30/2006 | 66FAK99SUPPRESSANT N.E.C. | 335LACKS N/C | New Orleans District Office (NOL-DO) |
| 10/30/2006 | 62FAO39SODIUM HYPOCHLORITE (SOL) (ANTI-INFECTIVE, TOPICAL) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Shop New Zealand's FDA import refusal history?
Shop New Zealand (FEI: 3005724881) has 4 FDA import refusal record(s) in our database, spanning from 10/30/2006 to 10/30/2006.
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. Shop New Zealand's FEI number is 3005724881.
What types of violations has Shop New Zealand received?
Shop New Zealand has been cited for 5 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 Shop New Zealand come from?
All FDA import refusal data for Shop New Zealand 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.