NEW LEADERS INTERNATIONAL LIMITE
⚠️ High Risk
FEI: 3020177615 • Hong Kong • HONG KONG
FEI Number
3020177615
Location
Hong Kong
Country
HONG KONGAddress
Flat C 22f Wing Cheong, , Hong Kong, , Hong Kong
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/28/2023 | 69AA99CATEGORY I, N.E.C., MEDICATED ANIMAL FEED | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/24/2023 | 65QCY02BOTOX | Division of Southeast Imports (DSEI) | |
| 2/24/2023 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/24/2023 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/17/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/10/2023 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2023 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/6/2023 | 65QDY02BOTOX | Division of Southeast Imports (DSEI) | |
| 1/31/2023 | 66VCJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NEW LEADERS INTERNATIONAL LIMITE's FDA import refusal history?
NEW LEADERS INTERNATIONAL LIMITE (FEI: 3020177615) has 9 FDA import refusal record(s) in our database, spanning from 1/31/2023 to 3/28/2023.
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. NEW LEADERS INTERNATIONAL LIMITE's FEI number is 3020177615.
What types of violations has NEW LEADERS INTERNATIONAL LIMITE received?
NEW LEADERS INTERNATIONAL LIMITE 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 NEW LEADERS INTERNATIONAL LIMITE come from?
All FDA import refusal data for NEW LEADERS INTERNATIONAL LIMITE 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.