Usa Worldwide Link (Hk) Trading Ltd
⚠️ Moderate Risk
FEI: 3008487914 • Kwai Chungkwai Chung • HONG KONG
FEI Number
3008487914
Location
Kwai Chungkwai Chung
Country
HONG KONGAddress
L3 10/F Bk4 Golden Dragon Ind Ctr182-190, , Kwai Chungkwai Chung, , 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
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).
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 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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
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.
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 PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/15/2011 | 89LXFDIATHERMY, ULTRASONIC, FOR USE OTHER THAN APPLYING THERAPEUTIC DEEP HEAT | Cincinnati District Office (CIN-DO) | |
| 11/15/2011 | 80DWLSTOCKING, MEDICAL SUPPORT | Cincinnati District Office (CIN-DO) | |
| 11/15/2011 | 89EGJDEVICE, IONTOPHORESIS, OTHER USES | Cincinnati District Office (CIN-DO) | |
| 10/10/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Usa Worldwide Link (Hk) Trading Ltd's FDA import refusal history?
Usa Worldwide Link (Hk) Trading Ltd (FEI: 3008487914) has 4 FDA import refusal record(s) in our database, spanning from 10/10/2011 to 11/15/2011.
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. Usa Worldwide Link (Hk) Trading Ltd's FEI number is 3008487914.
What types of violations has Usa Worldwide Link (Hk) Trading Ltd received?
Usa Worldwide Link (Hk) Trading Ltd has been cited for 7 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 Usa Worldwide Link (Hk) Trading Ltd come from?
All FDA import refusal data for Usa Worldwide Link (Hk) Trading 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.