Dongguan Yong Huang Optical Products Co., Ltd.
⚠️ Moderate Risk
FEI: 3003277351 • Dongguan City Guangdong • CHINA
FEI Number
3003277351
Location
Dongguan City Guangdong
Country
CHINAAddress
Li Heng District, Qing Xi Town, , Dongguan City 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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
Frequently Asked Questions
What is Dongguan Yong Huang Optical Products Co., Ltd.'s FDA import refusal history?
Dongguan Yong Huang Optical Products Co., Ltd. (FEI: 3003277351) has 1 FDA import refusal record(s) in our database, spanning from 11/2/2012 to 11/2/2012.
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 Yong Huang Optical Products Co., Ltd.'s FEI number is 3003277351.
What types of violations has Dongguan Yong Huang Optical Products Co., Ltd. received?
Dongguan Yong Huang Optical Products Co., Ltd. has been cited for 2 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 Yong Huang Optical Products Co., Ltd. come from?
All FDA import refusal data for Dongguan Yong Huang Optical Products 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.