Wenzhou Outlook Optical Co Ltd
⚠️ Moderate Risk
FEI: 3006624227 • Wenzhou, Zhejiang • CHINA
FEI Number
3006624227
Location
Wenzhou, Zhejiang
Country
CHINAAddress
F 27, Development Mansionxincheng Rd, Wenzhou, Zhejiang, 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
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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.
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 |
|---|---|---|---|
| 11/13/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 11/13/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 11/13/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 11/13/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 12/18/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New Orleans District Office (NOL-DO) |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | New Orleans District Office (NOL-DO) |
| 11/20/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 11/9/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | San Francisco District Office (SAN-DO) |
| 9/15/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 9/15/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 9/15/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 9/15/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 9/15/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 9/15/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 9/15/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 8/18/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 8/18/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 8/18/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 6/16/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 6/16/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | New York District Office (NYK-DO) |
| 5/21/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | Seattle District Office (SEA-DO) |
| 5/14/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | New England District Office (NWE-DO) |
| 5/14/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | New England District Office (NWE-DO) |
| 5/14/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | New England District Office (NWE-DO) |
| 5/14/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | New England District Office (NWE-DO) |
| 5/14/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | New England District Office (NWE-DO) |
| 8/28/2008 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Wenzhou Outlook Optical Co Ltd's FDA import refusal history?
Wenzhou Outlook Optical Co Ltd (FEI: 3006624227) has 27 FDA import refusal record(s) in our database, spanning from 8/28/2008 to 11/13/2019.
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 Outlook Optical Co Ltd's FEI number is 3006624227.
What types of violations has Wenzhou Outlook Optical Co Ltd received?
Wenzhou Outlook Optical Co Ltd has been cited for 3 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 Outlook Optical Co Ltd come from?
All FDA import refusal data for Wenzhou Outlook 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.