ZHEJIANG OUTLOOK EYEWEAR CO LTD
⚠️ Moderate Risk
FEI: 3007710647 • Wenzhoush, Zhejiang • CHINA
FEI Number
3007710647
Location
Wenzhoush, Zhejiang
Country
CHINAAddress
Light Industrial Park, Specialized 12 Luchengqu, Wenzhoush, 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 7/19/2022 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Southeast Imports (DSEI) |
| 4/23/2021 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Division of Northern Border Imports (DNBI) |
| 7/18/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 6/20/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 6/20/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 6/20/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 11/22/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | New Orleans District Office (NOL-DO) |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 11/12/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New Orleans District Office (NOL-DO) | |
| 6/30/2011 | 86HOISPECTACLE, MAGNIFYING | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is ZHEJIANG OUTLOOK EYEWEAR CO LTD's FDA import refusal history?
ZHEJIANG OUTLOOK EYEWEAR CO LTD (FEI: 3007710647) has 18 FDA import refusal record(s) in our database, spanning from 6/30/2011 to 7/19/2022.
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. ZHEJIANG OUTLOOK EYEWEAR CO LTD's FEI number is 3007710647.
What types of violations has ZHEJIANG OUTLOOK EYEWEAR CO LTD received?
ZHEJIANG OUTLOOK EYEWEAR CO LTD has been cited for 5 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 ZHEJIANG OUTLOOK EYEWEAR CO LTD come from?
All FDA import refusal data for ZHEJIANG OUTLOOK EYEWEAR 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.