HK YOUMAI TRADING LIMITED
⚠️ Moderate Risk
FEI: 3018206247 • San Po Kong • HONG KONG
FEI Number
3018206247
Location
San Po Kong
Country
HONG KONGAddress
Flat 17 Blk 07 Yip Fungbldg, , San Po 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
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).
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/27/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Southeast Imports (DSEI) | |
| 4/27/2021 | 79OOKDERMAL COOLING PACK/VACUUM/MASSAGER | Division of Southeast Imports (DSEI) | |
| 4/27/2021 | 79OHSLIGHT BASED OVER THE COUNTER WRINKLE REDUCTION | Division of Southeast Imports (DSEI) | |
| 4/27/2021 | 87NBNGENERATOR, SHOCK-WAVE, (FOR PAIN RELIEF) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HK YOUMAI TRADING LIMITED's FDA import refusal history?
HK YOUMAI TRADING LIMITED (FEI: 3018206247) has 4 FDA import refusal record(s) in our database, spanning from 4/27/2021 to 4/27/2021.
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. HK YOUMAI TRADING LIMITED's FEI number is 3018206247.
What types of violations has HK YOUMAI TRADING LIMITED received?
HK YOUMAI TRADING LIMITED has been cited for 5 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 HK YOUMAI TRADING LIMITED come from?
All FDA import refusal data for HK YOUMAI TRADING 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.