SPARK WIN COMPANY LIMITED
✅ Low Risk
FEI: 3015859973 • Cheung Sha Wan • HONG KONG
FEI Number
3015859973
Location
Cheung Sha Wan
Country
HONG KONGAddress
Flat C 4/F Wing Hong Ctr 18, , Cheung Sha Wan, , Hong Kong
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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.
Refusal History
Frequently Asked Questions
What is SPARK WIN COMPANY LIMITED's FDA import refusal history?
SPARK WIN COMPANY LIMITED (FEI: 3015859973) has 1 FDA import refusal record(s) in our database, spanning from 6/18/2020 to 6/18/2020.
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. SPARK WIN COMPANY LIMITED's FEI number is 3015859973.
What types of violations has SPARK WIN COMPANY LIMITED received?
SPARK WIN COMPANY LIMITED has been cited for 2 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 SPARK WIN COMPANY LIMITED come from?
All FDA import refusal data for SPARK WIN 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.