ENDEAVOUR CONSUMER HEALTH
⚠️ Moderate Risk
FEI: 3016082252 • Auckland • NEW ZEALAND
FEI Number
3016082252
Location
Auckland
Country
NEW ZEALANDAddress
17a Landing Drive, Albany, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/22/2021 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/22/2021 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/22/2021 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/22/2021 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northern Border Imports (DNBI) | |
| 12/22/2021 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is ENDEAVOUR CONSUMER HEALTH's FDA import refusal history?
ENDEAVOUR CONSUMER HEALTH (FEI: 3016082252) has 5 FDA import refusal record(s) in our database, spanning from 12/22/2021 to 12/22/2021.
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. ENDEAVOUR CONSUMER HEALTH's FEI number is 3016082252.
What types of violations has ENDEAVOUR CONSUMER HEALTH received?
ENDEAVOUR CONSUMER HEALTH has been cited for 4 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 ENDEAVOUR CONSUMER HEALTH come from?
All FDA import refusal data for ENDEAVOUR CONSUMER HEALTH 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.