Taizhou City Chuntian Glasses Co Ltd
⚠️ Moderate Risk
FEI: 3010139734 • Taizhou, Zhejiang • CHINA
FEI Number
3010139734
Location
Taizhou, Zhejiang
Country
CHINAAddress
Dunan And Xinxing Intersection, Duqiaozhen Linhai, Taizhou, 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 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.
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 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(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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/23/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Cincinnati District Office (CIN-DO) | |
| 8/7/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 4/15/2015 | 86HOISPECTACLE, MAGNIFYING | Los Angeles District Office (LOS-DO) | |
| 4/15/2015 | 86HOISPECTACLE, MAGNIFYING | Los Angeles District Office (LOS-DO) | |
| 4/15/2015 | 86HOISPECTACLE, MAGNIFYING | Los Angeles District Office (LOS-DO) | |
| 4/15/2015 | 86HOISPECTACLE, MAGNIFYING | Los Angeles District Office (LOS-DO) | |
| 4/15/2015 | 86HOISPECTACLE, MAGNIFYING | Los Angeles District Office (LOS-DO) | |
| 4/15/2015 | 86HOISPECTACLE, MAGNIFYING | Los Angeles District Office (LOS-DO) | |
| 10/24/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 10/8/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Cincinnati District Office (CIN-DO) | |
| 7/24/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Taizhou City Chuntian Glasses Co Ltd's FDA import refusal history?
Taizhou City Chuntian Glasses Co Ltd (FEI: 3010139734) has 11 FDA import refusal record(s) in our database, spanning from 7/24/2013 to 10/23/2015.
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. Taizhou City Chuntian Glasses Co Ltd's FEI number is 3010139734.
What types of violations has Taizhou City Chuntian Glasses Co Ltd received?
Taizhou City Chuntian Glasses Co Ltd has been cited for 6 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 Taizhou City Chuntian Glasses Co Ltd come from?
All FDA import refusal data for Taizhou City Chuntian Glasses 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.