Fortuna Optical Factory Ltd.
✅ Low Risk
FEI: 3003418134 • Shenzhen • CHINA
FEI Number
3003418134
Location
Shenzhen
Country
CHINAAddress
Chung Kono Baoan, Sha Bu Wei, , Shenzhen, , China
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/14/2008 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Fortuna Optical Factory Ltd.'s FDA import refusal history?
Fortuna Optical Factory Ltd. (FEI: 3003418134) has 1 FDA import refusal record(s) in our database, spanning from 5/14/2008 to 5/14/2008.
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. Fortuna Optical Factory Ltd.'s FEI number is 3003418134.
What types of violations has Fortuna Optical Factory Ltd. received?
Fortuna Optical Factory Ltd. 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 Fortuna Optical Factory Ltd. come from?
All FDA import refusal data for Fortuna Optical Factory 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.