JIANGXI LOOK OPTICAL INDUSTRIAL CO., LTD.
✅ Low Risk
FEI: 3010515922 • Shangrao, Jiangxi • CHINA
FEI Number
3010515922
Location
Shangrao, Jiangxi
Country
CHINAAddress
Po Yang County, Zone Lutianjizhen, Shangrao, Jiangxi, 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 |
|---|---|---|---|
| 4/23/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 4/23/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 4/23/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is JIANGXI LOOK OPTICAL INDUSTRIAL CO., LTD.'s FDA import refusal history?
JIANGXI LOOK OPTICAL INDUSTRIAL CO., LTD. (FEI: 3010515922) has 3 FDA import refusal record(s) in our database, spanning from 4/23/2015 to 4/23/2015.
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. JIANGXI LOOK OPTICAL INDUSTRIAL CO., LTD.'s FEI number is 3010515922.
What types of violations has JIANGXI LOOK OPTICAL INDUSTRIAL CO., LTD. received?
JIANGXI LOOK OPTICAL INDUSTRIAL CO., 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 JIANGXI LOOK OPTICAL INDUSTRIAL CO., LTD. come from?
All FDA import refusal data for JIANGXI LOOK OPTICAL INDUSTRIAL 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.