Shanghai Conant Optics Co., Inc.
⚠️ Moderate Risk
FEI: 3002871163 • Shanghai, Shanghai • CHINA
FEI Number
3002871163
Location
Shanghai, Shanghai
Country
CHINAAddress
555 Chuandalu, Pudongxin, Shanghai, Shanghai, China
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
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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/30/2025 | 86HOISPECTACLE, MAGNIFYING | 231LENS CERT | Division of West Coast Imports (DWCI) |
| 6/30/2025 | 86HOISPECTACLE, MAGNIFYING | 231LENS CERT | Division of West Coast Imports (DWCI) |
| 5/2/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | Division of West Coast Imports (DWCI) | |
| 12/27/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 12/27/2023 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 3/6/2009 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Shanghai Conant Optics Co., Inc.'s FDA import refusal history?
Shanghai Conant Optics Co., Inc. (FEI: 3002871163) has 6 FDA import refusal record(s) in our database, spanning from 3/6/2009 to 6/30/2025.
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. Shanghai Conant Optics Co., Inc.'s FEI number is 3002871163.
What types of violations has Shanghai Conant Optics Co., Inc. received?
Shanghai Conant Optics Co., Inc. 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 Shanghai Conant Optics Co., Inc. come from?
All FDA import refusal data for Shanghai Conant Optics Co., Inc. 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.