GMBX GROUP HONG KONG LIMITED
⚠️ Moderate Risk
FEI: 3019981048 • Kwai Chung • HONG KONG
FEI Number
3019981048
Location
Kwai Chung
Country
HONG KONGAddress
Flat 2402 24/F Wah Fatindustrial B, , Kwai 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
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
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).
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 |
|---|---|---|---|
| 3/18/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 3/10/2022 | 86LRXCASE, CONTACT LENS | Division of Southeast Imports (DSEI) | |
| 3/10/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GMBX GROUP HONG KONG LIMITED's FDA import refusal history?
GMBX GROUP HONG KONG LIMITED (FEI: 3019981048) has 3 FDA import refusal record(s) in our database, spanning from 3/10/2022 to 3/18/2022.
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. GMBX GROUP HONG KONG LIMITED's FEI number is 3019981048.
What types of violations has GMBX GROUP HONG KONG LIMITED received?
GMBX GROUP HONG KONG LIMITED 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 GMBX GROUP HONG KONG LIMITED come from?
All FDA import refusal data for GMBX GROUP HONG KONG 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.