Hong Kong Intl Co Ltd
⚠️ High Risk
FEI: 3007065509 • Ningbo, Zhejiang • CHINA
FEI Number
3007065509
Location
Ningbo, Zhejiang
Country
CHINAAddress
158 Huancheng North Rd Xiduan, , Ningbo, Zhejiang, China
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2008 | 53LA04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/12/2008 | 66FBJ99SUPPRESSANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/12/2008 | 66FBJ99SUPPRESSANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/20/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2008 | 66FBJ99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/20/2008 | 89IMAPACK, HEAT, MOIST | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Hong Kong Intl Co Ltd's FDA import refusal history?
Hong Kong Intl Co Ltd (FEI: 3007065509) has 9 FDA import refusal record(s) in our database, spanning from 10/20/2008 to 12/12/2008.
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. Hong Kong Intl Co Ltd's FEI number is 3007065509.
What types of violations has Hong Kong Intl Co Ltd received?
Hong Kong Intl Co Ltd has been cited for 2 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 Hong Kong Intl Co Ltd come from?
All FDA import refusal data for Hong Kong Intl Co 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.