Wenzhou Croesus Optical Co., Ltd.
⚠️ High Risk
FEI: 3008044475 • Wenzhou, Zhejiang • CHINA
FEI
FEI Number
3008044475
📍
Location
Wenzhou, Zhejiang
🇨🇳
Country
CHINA🏢
Address
Xinyi Mansion Room A802 Floor 8, Shifulu; Lucheng, Wenzhou, Zhejiang, China
High Risk
FDA Import Risk Assessment
66.5
LowModerateHighCritical
This firm has a significant history of FDA import refusals with notable violations.
Statistics
63
Total Refusals
1
Unique Violations
2/24/2025
Latest Refusal
2/24/2025
Earliest Refusal
Score Breakdown
Violation Severity
50.0×40%
Refusal Volume
66.9×30%
Recency
82.3×20%
Frequency
100.0×10%
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
11863×
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2025 | 86HOISPECTACLE, MAGNIFYING | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Wenzhou Croesus Optical Co., Ltd.'s FDA import refusal history?
Wenzhou Croesus Optical Co., Ltd. (FEI: 3008044475) has 63 FDA import refusal record(s) in our database, spanning from 2/24/2025 to 2/24/2025.
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. Wenzhou Croesus Optical Co., Ltd.'s FEI number is 3008044475.
What types of violations has Wenzhou Croesus Optical Co., Ltd. received?
Wenzhou Croesus Optical 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 Wenzhou Croesus Optical Co., Ltd. come from?
All FDA import refusal data for Wenzhou Croesus Optical 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.