Wenzhou Dongtian Glasses Manufacture Co., Ltd.
⚠️ High Risk
FEI: 3005519018 • Wenzhou, Zhejiang • CHINA
FEI Number
3005519018
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Jugao Road, Ju Guang Garden 16, Dezhen Industrial Area, Wenzhou, Zhejiang, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
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).
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 IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 341REGISTERED | Division of Southwest Imports (DSWI) |
| 8/13/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 341REGISTERED | Division of Southwest Imports (DSWI) |
| 8/13/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 341REGISTERED | Division of Southwest Imports (DSWI) |
| 8/13/2025 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | 341REGISTERED | Division of Southwest Imports (DSWI) |
| 8/13/2025 | 86HOISPECTACLE, MAGNIFYING | 341REGISTERED | Division of Southwest Imports (DSWI) |
| 6/4/2021 | 86HOISPECTACLE, MAGNIFYING | Division of Northern Border Imports (DNBI) | |
| 7/13/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 4/19/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 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) |
| 5/24/2017 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Division of Northern Border Imports (DNBI) |
| 5/24/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Northern Border Imports (DNBI) |
| 6/17/2016 | 86HQZFRAME, SPECTACLE | Cincinnati District Office (CIN-DO) | |
| 1/25/2016 | 86NJHLENS, SPECTACLE (PRESCRIPTION), FOR READING DISCOMFORT | New Orleans District Office (NOL-DO) | |
| 11/27/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | San Francisco District Office (SAN-DO) | |
| 12/24/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3280FRNMFGREG | Cincinnati District Office (CIN-DO) |
| 11/17/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 231LENS CERT | Los Angeles District Office (LOS-DO) |
| 9/11/2014 | 86HOISPECTACLE, MAGNIFYING | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Wenzhou Dongtian Glasses Manufacture Co., Ltd.'s FDA import refusal history?
Wenzhou Dongtian Glasses Manufacture Co., Ltd. (FEI: 3005519018) has 18 FDA import refusal record(s) in our database, spanning from 9/11/2014 to 8/13/2025.
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 Dongtian Glasses Manufacture Co., Ltd.'s FEI number is 3005519018.
What types of violations has Wenzhou Dongtian Glasses Manufacture Co., Ltd. received?
Wenzhou Dongtian Glasses Manufacture 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 Wenzhou Dongtian Glasses Manufacture Co., Ltd. come from?
All FDA import refusal data for Wenzhou Dongtian Glasses Manufacture 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.