Honey Collection Ltd
⚠️ Moderate Risk
FEI: 3003711437 • Blenheim, Marlborough • NEW ZEALAND
FEI Number
3003711437
Location
Blenheim, Marlborough
Country
NEW ZEALANDAddress
69 Grove Road, Mayfield, Blenheim, Marlborough, 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
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/16/2021 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 11/16/2021 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 72NEW VET DR | Division of West Coast Imports (DWCI) |
| 6/24/2019 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 6/24/2019 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 4/9/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 4/9/2018 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 72NEW VET DR | Division of Northern Border Imports (DNBI) |
| 6/26/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | San Francisco District Office (SAN-DO) |
| 4/15/2014 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Honey Collection Ltd's FDA import refusal history?
Honey Collection Ltd (FEI: 3003711437) has 8 FDA import refusal record(s) in our database, spanning from 4/15/2014 to 11/16/2021.
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. Honey Collection Ltd's FEI number is 3003711437.
What types of violations has Honey Collection Ltd received?
Honey Collection Ltd has been cited for 6 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 Honey Collection Ltd come from?
All FDA import refusal data for Honey Collection 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.