INTCO MEDICAL INTERNATIONAL (HONG KONG) CO., LIMITED
⚠️ Moderate Risk
FEI: 3010287987 • Hong Kong, Hong Kong • HONG KONG
FEI Number
3010287987
Location
Hong Kong, Hong Kong
Country
HONG KONGAddress
LEVEL 54, HOPEWELL CENTRE, 183 QUEENS ROAD EAST, Hong Kong, Hong Kong, Hong Kong
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
3905
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 |
|---|---|---|---|
| 11/19/2024 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | Division of West Coast Imports (DWCI) | |
| 6/16/2023 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northern Border Imports (DNBI) |
| 5/20/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
| 3/17/2014 | 80LYZGLOVE, PATIENT EXAMINATION, VINYL | 477HOLES | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is INTCO MEDICAL INTERNATIONAL (HONG KONG) CO., LIMITED's FDA import refusal history?
INTCO MEDICAL INTERNATIONAL (HONG KONG) CO., LIMITED (FEI: 3010287987) has 4 FDA import refusal record(s) in our database, spanning from 3/17/2014 to 11/19/2024.
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. INTCO MEDICAL INTERNATIONAL (HONG KONG) CO., LIMITED's FEI number is 3010287987.
What types of violations has INTCO MEDICAL INTERNATIONAL (HONG KONG) CO., LIMITED received?
INTCO MEDICAL INTERNATIONAL (HONG KONG) CO., LIMITED 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 INTCO MEDICAL INTERNATIONAL (HONG KONG) CO., LIMITED come from?
All FDA import refusal data for INTCO MEDICAL INTERNATIONAL (HONG KONG) CO., 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.