Jusda International Ltd
⚠️ Moderate Risk
FEI: 3011204851 • Hong Kong • HONG KONG
FEI Number
3011204851
Location
Hong Kong
Country
HONG KONGAddress
Dd 125 Ha Tsuen Road, , 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 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.
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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/24/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 4/24/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 4/24/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of Northern Border Imports (DNBI) | |
| 4/7/2016 | 80LDQDEVICE, GENERAL MEDICAL | Cincinnati District Office (CIN-DO) | |
| 12/18/2015 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 9/17/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Cincinnati District Office (CIN-DO) |
| 3/9/2015 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Jusda International Ltd's FDA import refusal history?
Jusda International Ltd (FEI: 3011204851) has 7 FDA import refusal record(s) in our database, spanning from 3/9/2015 to 4/24/2019.
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. Jusda International Ltd's FEI number is 3011204851.
What types of violations has Jusda International Ltd received?
Jusda International Ltd has been cited for 6 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 Jusda International Ltd come from?
All FDA import refusal data for Jusda International 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.