Manuka Health New Zealand Ltd.
⚠️ Moderate Risk
FEI: 2000026235 • Te Awamutu, Waikato • NEW ZEALAND
FEI Number
2000026235
Location
Te Awamutu, Waikato
Country
NEW ZEALANDAddress
Carlton Street, , Te Awamutu, Waikato, 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
NUTRIT LBL
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 fails to bear the required nutrition information.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
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 |
|---|---|---|---|
| 8/1/2014 | 54FCQ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 8/1/2014 | 36CGT99HONEY, N.E.C. | Chicago District Office (CHI-DO) | |
| 8/1/2014 | 36CCT03WHIPPED HONEY | 482NUTRIT LBL | Chicago District Office (CHI-DO) |
| 8/1/2014 | 36CCT03WHIPPED HONEY | 482NUTRIT LBL | Chicago District Office (CHI-DO) |
| 8/1/2014 | 36CCT03WHIPPED HONEY | 482NUTRIT LBL | Chicago District Office (CHI-DO) |
| 8/1/2014 | 33CYY99HARD CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 482NUTRIT LBL | Chicago District Office (CHI-DO) |
| 8/1/2014 | 36CCC03WHIPPED HONEY | 482NUTRIT LBL | Chicago District Office (CHI-DO) |
| 8/1/2014 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 251POISONOUS | Chicago District Office (CHI-DO) |
| 8/1/2014 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 251POISONOUS | Chicago District Office (CHI-DO) |
| 8/1/2014 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 251POISONOUS | Chicago District Office (CHI-DO) |
| 8/1/2014 | 36CCT03WHIPPED HONEY | 251POISONOUS | Chicago District Office (CHI-DO) |
| 8/1/2014 | 36CCT03WHIPPED HONEY | 251POISONOUS | Chicago District Office (CHI-DO) |
| 8/29/2013 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Manuka Health New Zealand Ltd.'s FDA import refusal history?
Manuka Health New Zealand Ltd. (FEI: 2000026235) has 13 FDA import refusal record(s) in our database, spanning from 8/29/2013 to 8/1/2014.
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. Manuka Health New Zealand Ltd.'s FEI number is 2000026235.
What types of violations has Manuka Health New Zealand Ltd. received?
Manuka Health New Zealand Ltd. 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 Manuka Health New Zealand Ltd. come from?
All FDA import refusal data for Manuka Health New Zealand Ltd. 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.