GLAMSTAR LIMITED
⚠️ High Risk
FEI: 3021909873 • Mong Kok • HONG KONG
FEI Number
3021909873
Location
Mong Kok
Country
HONG KONGAddress
Flat B 11/Fl Full Wingcomm. Ctr 57, , Mong Kok, , Hong Kong
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/28/2022 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 6/28/2022 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of West Coast Imports (DWCI) | |
| 6/28/2022 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of West Coast Imports (DWCI) | |
| 6/28/2022 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of West Coast Imports (DWCI) | |
| 6/1/2022 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 5/25/2022 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 5/25/2022 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/25/2022 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/18/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of West Coast Imports (DWCI) | |
| 5/18/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of West Coast Imports (DWCI) | |
| 5/18/2022 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | Division of West Coast Imports (DWCI) | |
| 5/18/2022 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/18/2022 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/18/2022 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/18/2022 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 4/18/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of West Coast Imports (DWCI) | |
| 4/18/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of West Coast Imports (DWCI) | |
| 4/18/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of West Coast Imports (DWCI) | |
| 4/18/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of West Coast Imports (DWCI) | |
| 4/18/2022 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of West Coast Imports (DWCI) | |
| 4/18/2022 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | Division of West Coast Imports (DWCI) | |
| 4/18/2022 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is GLAMSTAR LIMITED's FDA import refusal history?
GLAMSTAR LIMITED (FEI: 3021909873) has 22 FDA import refusal record(s) in our database, spanning from 4/18/2022 to 6/28/2022.
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. GLAMSTAR LIMITED's FEI number is 3021909873.
What types of violations has GLAMSTAR LIMITED received?
GLAMSTAR 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 GLAMSTAR LIMITED come from?
All FDA import refusal data for GLAMSTAR 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.