ZHEJIANG NEW VISION IMP.& EXP.CO.,LTD.
⚠️ Moderate Risk
FEI: 3009998957 • Ningbo, Zhejiang • CHINA
FEI Number
3009998957
Location
Ningbo, Zhejiang
Country
CHINAAddress
Building No.1 F. 14, Jingjia Road,Ningbo 315040 China, Ningbo, 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
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/25/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 5/30/2013 | 25SGH99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | 249FILTHY | San Francisco District Office (SAN-DO) |
| 5/30/2013 | 25SGH99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | 249FILTHY | San Francisco District Office (SAN-DO) |
| 5/30/2013 | 25SGH99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | 249FILTHY | San Francisco District Office (SAN-DO) |
| 5/30/2013 | 25SGH99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | 249FILTHY | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is ZHEJIANG NEW VISION IMP.& EXP.CO.,LTD.'s FDA import refusal history?
ZHEJIANG NEW VISION IMP.& EXP.CO.,LTD. (FEI: 3009998957) has 5 FDA import refusal record(s) in our database, spanning from 5/30/2013 to 2/25/2016.
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 NEW VISION IMP.& EXP.CO.,LTD.'s FEI number is 3009998957.
What types of violations has ZHEJIANG NEW VISION IMP.& EXP.CO.,LTD. received?
ZHEJIANG NEW VISION IMP.& EXP.CO.,LTD. has been cited for 4 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 NEW VISION IMP.& EXP.CO.,LTD. come from?
All FDA import refusal data for ZHEJIANG NEW VISION IMP.& EXP.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.