ZHENGZHOU HUAER ELECTRO-OPTICS
⚠️ Moderate Risk
FEI: 3030415323 • Zhengzhou • CHINA
FEI Number
3030415323
Location
Zhengzhou
Country
CHINAAddress
(Spb-A)(Chm)(Lb) No.A13zhongyuanxi, Zhongyuan Industry Park, Zhengzhou, , 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
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
Frequently Asked Questions
What is ZHENGZHOU HUAER ELECTRO-OPTICS's FDA import refusal history?
ZHENGZHOU HUAER ELECTRO-OPTICS (FEI: 3030415323) has 1 FDA import refusal record(s) in our database, spanning from 9/16/2025 to 9/16/2025.
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. ZHENGZHOU HUAER ELECTRO-OPTICS's FEI number is 3030415323.
What types of violations has ZHENGZHOU HUAER ELECTRO-OPTICS received?
ZHENGZHOU HUAER ELECTRO-OPTICS 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 ZHENGZHOU HUAER ELECTRO-OPTICS come from?
All FDA import refusal data for ZHENGZHOU HUAER ELECTRO-OPTICS 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.