Zhejiang Materials Chemical and Light Industry Co ltd
⚠️ Moderate Risk
FEI: 3003937902 • Hangzhou, Zhejiang • CHINA
FEI Number
3003937902
Location
Hangzhou, Zhejiang
Country
CHINAAddress
A/10f, F1, Guodu Developing Mansion, 182 Chaohui Road, Hangzhou, 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
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2005 | 60QAO56BENZOCAINE (ANESTHETIC) | New York District Office (NYK-DO) | |
| 3/19/2003 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Southwest Import District Office (SWI-DO) | |
| 3/19/2003 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Southwest Import District Office (SWI-DO) | |
| 3/19/2003 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Southwest Import District Office (SWI-DO) | |
| 3/19/2003 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Zhejiang Materials Chemical and Light Industry Co ltd's FDA import refusal history?
Zhejiang Materials Chemical and Light Industry Co ltd (FEI: 3003937902) has 5 FDA import refusal record(s) in our database, spanning from 3/19/2003 to 4/5/2005.
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 Materials Chemical and Light Industry Co ltd's FEI number is 3003937902.
What types of violations has Zhejiang Materials Chemical and Light Industry Co ltd received?
Zhejiang Materials Chemical and Light Industry 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 Materials Chemical and Light Industry Co ltd come from?
All FDA import refusal data for Zhejiang Materials Chemical and Light Industry 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.