Mitoq Limited
⚠️ Moderate Risk
FEI: 3010948637 • Auckland • NEW ZEALAND
FEI Number
3010948637
Location
Auckland
Country
NEW ZEALANDAddress
Level 2, 16 Viaduct Harbour Avenue, 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
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 |
|---|---|---|---|
| 8/22/2019 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 10/15/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/15/2014 | 54ACC90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Mitoq Limited's FDA import refusal history?
Mitoq Limited (FEI: 3010948637) has 3 FDA import refusal record(s) in our database, spanning from 10/15/2014 to 8/22/2019.
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. Mitoq Limited's FEI number is 3010948637.
What types of violations has Mitoq Limited received?
Mitoq 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 Mitoq Limited come from?
All FDA import refusal data for Mitoq 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.