FIGURELAXY COMPANY LIMITED
⚠️ Moderate Risk
FEI: 3033471367 • Kwai Chung, New Territories • HONG KONG
FEI Number
3033471367
Location
Kwai Chung, New Territories
Country
HONG KONGAddress
Unit 708 On, 7th Floor, Regent Centre Tower B; 70 Ta Chuen Ping Street, Kwai Chung, New Territories, 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.
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
Frequently Asked Questions
What is FIGURELAXY COMPANY LIMITED's FDA import refusal history?
FIGURELAXY COMPANY LIMITED (FEI: 3033471367) has 2 FDA import refusal record(s) in our database, spanning from 4/14/2025 to 4/14/2025.
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. FIGURELAXY COMPANY LIMITED's FEI number is 3033471367.
What types of violations has FIGURELAXY COMPANY LIMITED received?
FIGURELAXY COMPANY LIMITED has been cited for 3 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 FIGURELAXY COMPANY LIMITED come from?
All FDA import refusal data for FIGURELAXY 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.