Topace Innovation Co., Ltd.
✅ Low Risk
FEI: 3003831316 • Hong Kong • HONG KONG
FEI Number
3003831316
Location
Hong Kong
Country
HONG KONGAddress
Rm 4-6, 9/F Singga Comm Centrs, 149, , Hong Kong, , 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
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).
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.
Refusal History
Frequently Asked Questions
What is Topace Innovation Co., Ltd.'s FDA import refusal history?
Topace Innovation Co., Ltd. (FEI: 3003831316) has 1 FDA import refusal record(s) in our database, spanning from 6/11/2003 to 6/11/2003.
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. Topace Innovation Co., Ltd.'s FEI number is 3003831316.
What types of violations has Topace Innovation Co., Ltd. received?
Topace Innovation Co., Ltd. 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 Topace Innovation Co., Ltd. come from?
All FDA import refusal data for Topace Innovation Co., Ltd. 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.