Wenzhou M & C Foreign Trade Co., Ltd.
⚠️ High Risk
FEI: 3003499479 • Wenzhou, Zhejiang • CHINA
FEI Number
3003499479
Location
Wenzhou, Zhejiang
Country
CHINAAddress
26th Fl., NO. 8 Liming West Road, 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
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).
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.
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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 |
|---|---|---|---|
| 2/26/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 5/12/2022 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 5/18/2021 | 86HOISPECTACLE, MAGNIFYING | Division of Southeast Imports (DSEI) | |
| 1/4/2021 | 86HQZFRAME, SPECTACLE | Division of Southeast Imports (DSEI) | |
| 7/22/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 7/21/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 12/5/2019 | 86HOISPECTACLE, MAGNIFYING | Division of West Coast Imports (DWCI) | |
| 7/17/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/17/2018 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 3/14/2018 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 2/9/2018 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/15/2017 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Division of Northern Border Imports (DNBI) | |
| 12/11/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 7/18/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 6/23/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Southeast Imports (DSEI) |
| 6/6/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 6/2/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 5/3/2017 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 1/17/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New York District Office (NYK-DO) |
| 1/17/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Northeast Imports (DNEI) |
| 1/17/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Northeast Imports (DNEI) |
| 11/3/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New York District Office (NYK-DO) |
| 8/11/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
| 8/5/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | New York District Office (NYK-DO) | |
| 6/29/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 6/29/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 6/29/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 4/28/2015 | 86HOHSPECTACLE, OPERATING (LOUPE), OPHTHALMIC | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 3/9/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northeast Imports (DNEI) | |
| 9/4/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) | |
| 5/5/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 1/28/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 9/23/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Los Angeles District Office (LOS-DO) | |
| 7/8/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Philadelphia District Office (PHI-DO) |
| 2/21/2013 | 66BAY44NICOTINE DELIVERY SYSTEM | New Orleans District Office (NOL-DO) | |
| 8/15/2012 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 231LENS CERT | Los Angeles District Office (LOS-DO) |
| 6/15/2012 | 86HQZFRAME, SPECTACLE | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 7/23/2010 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/23/2010 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/23/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Detroit District Office (DET-DO) |
| 2/26/2010 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/6/2009 | 86HOISPECTACLE, MAGNIFYING | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 5/21/2007 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Los Angeles District Office (LOS-DO) | |
| 7/11/2003 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 2/12/2002 | 86HQHEYE, ARTIFICIAL, NON-CUSTOM | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Wenzhou M & C Foreign Trade Co., Ltd.'s FDA import refusal history?
Wenzhou M & C Foreign Trade Co., Ltd. (FEI: 3003499479) has 45 FDA import refusal record(s) in our database, spanning from 2/12/2002 to 2/26/2025.
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 M & C Foreign Trade Co., Ltd.'s FEI number is 3003499479.
What types of violations has Wenzhou M & C Foreign Trade Co., Ltd. received?
Wenzhou M & C Foreign Trade Co., Ltd. has been cited for 10 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 M & C Foreign Trade Co., Ltd. come from?
All FDA import refusal data for Wenzhou M & C Foreign Trade 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.