Siu Woo Co.
✅ Low Risk
FEI: 1000439612 • Sheung Wan, Hong Kong Island • HONG KONG
FEI Number
1000439612
Location
Sheung Wan, Hong Kong Island
Country
HONG KONGAddress
E, 94 Bonham Strand, Sheung Wan, Hong Kong Island, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2008 | 77JZESPOON, EAR | 118NOT LISTED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Siu Woo Co.'s FDA import refusal history?
Siu Woo Co. (FEI: 1000439612) has 1 FDA import refusal record(s) in our database, spanning from 12/15/2008 to 12/15/2008.
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. Siu Woo Co.'s FEI number is 1000439612.
What types of violations has Siu Woo Co. received?
Siu Woo Co. has been cited for 1 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 Siu Woo Co. come from?
All FDA import refusal data for Siu Woo Co. 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.