KATHYER COMPANY LIMITED
⚠️ Moderate Risk
FEI: 3016172565 • Mong Kok, Kowloon • HONG KONG
FEI Number
3016172565
Location
Mong Kok, Kowloon
Country
HONG KONGAddress
1/F, Winner Mansion; 691a Nathan Road, Mong Kok, Kowloon, 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.
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.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2021 | 90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC | Division of Southeast Imports (DSEI) | |
| 2/12/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/9/2020 | 74DXQCUFF, BLOOD-PRESSURE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is KATHYER COMPANY LIMITED's FDA import refusal history?
KATHYER COMPANY LIMITED (FEI: 3016172565) has 3 FDA import refusal record(s) in our database, spanning from 12/9/2020 to 5/6/2021.
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. KATHYER COMPANY LIMITED's FEI number is 3016172565.
What types of violations has KATHYER COMPANY LIMITED received?
KATHYER COMPANY 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 KATHYER COMPANY LIMITED come from?
All FDA import refusal data for KATHYER COMPANY 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.