LIKEX COMPANY LIMITED
⚠️ Moderate Risk
FEI: 3016686530 • Cheung Sha Wan • HONG KONG
FEI Number
3016686530
Location
Cheung Sha Wan
Country
HONG KONGAddress
Flat C, 4/F, 18, Wing Hong Ctr Wing Hong St Cheung, Cheung Sha Wan, , 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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/20/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 1/20/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 6/4/2021 | 73CAFNEBULIZER (DIRECT PATIENT INTERFACE) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LIKEX COMPANY LIMITED's FDA import refusal history?
LIKEX COMPANY LIMITED (FEI: 3016686530) has 3 FDA import refusal record(s) in our database, spanning from 6/4/2021 to 1/20/2022.
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. LIKEX COMPANY LIMITED's FEI number is 3016686530.
What types of violations has LIKEX COMPANY LIMITED received?
LIKEX 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 LIKEX COMPANY LIMITED come from?
All FDA import refusal data for LIKEX 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.