SUNVALLEY (HK) TECHNOLOGY LIMITED
⚠️ Moderate Risk
FEI: 3020750091 • Admiralty • HONG KONG
FEI Number
3020750091
Location
Admiralty
Country
HONG KONGAddress
Room 1003, 10/F, Tower 1 Lippo Centre; 89 Queensway, Admiralty, , 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
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.
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).
Refusal History
Frequently Asked Questions
What is SUNVALLEY (HK) TECHNOLOGY LIMITED's FDA import refusal history?
SUNVALLEY (HK) TECHNOLOGY LIMITED (FEI: 3020750091) has 1 FDA import refusal record(s) in our database, spanning from 1/23/2023 to 1/23/2023.
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. SUNVALLEY (HK) TECHNOLOGY LIMITED's FEI number is 3020750091.
What types of violations has SUNVALLEY (HK) TECHNOLOGY LIMITED received?
SUNVALLEY (HK) TECHNOLOGY 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 SUNVALLEY (HK) TECHNOLOGY LIMITED come from?
All FDA import refusal data for SUNVALLEY (HK) TECHNOLOGY 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.