Dongguan Zhan Yimetal & Electrical Products Co.
⚠️ Moderate Risk
FEI: 3002857181 • Guangdong • CHINA
FEI Number
3002857181
Location
Guangdong
Country
CHINAAddress
Jin-Chyan Ind. District, Ching-Shi Town,, , Guangdong, , 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).
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.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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.
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
Frequently Asked Questions
What is Dongguan Zhan Yimetal & Electrical Products Co.'s FDA import refusal history?
Dongguan Zhan Yimetal & Electrical Products Co. (FEI: 3002857181) has 2 FDA import refusal record(s) in our database, spanning from 8/23/2011 to 12/2/2011.
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. Dongguan Zhan Yimetal & Electrical Products Co.'s FEI number is 3002857181.
What types of violations has Dongguan Zhan Yimetal & Electrical Products Co. received?
Dongguan Zhan Yimetal & Electrical Products Co. 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 Dongguan Zhan Yimetal & Electrical Products Co. come from?
All FDA import refusal data for Dongguan Zhan Yimetal & Electrical Products Co. 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.