CHANGZHOU HUADA KEJIE OPTO-ELECT
⚠️ Moderate Risk
FEI: 3013586810 • Changzhou • CHINA
FEI Number
3013586810
Location
Changzhou
Country
CHINAAddress
No. 16 Meihua Road,Zhon, Jiangsu 21 Development District, Changzhou, , 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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/4/2019 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR | Division of Southwest Imports (DSWI) |
| 11/1/2019 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR | Division of Southwest Imports (DSWI) |
| 8/14/2019 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is CHANGZHOU HUADA KEJIE OPTO-ELECT's FDA import refusal history?
CHANGZHOU HUADA KEJIE OPTO-ELECT (FEI: 3013586810) has 3 FDA import refusal record(s) in our database, spanning from 8/14/2019 to 11/4/2019.
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. CHANGZHOU HUADA KEJIE OPTO-ELECT's FEI number is 3013586810.
What types of violations has CHANGZHOU HUADA KEJIE OPTO-ELECT received?
CHANGZHOU HUADA KEJIE OPTO-ELECT has been cited for 1 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 CHANGZHOU HUADA KEJIE OPTO-ELECT come from?
All FDA import refusal data for CHANGZHOU HUADA KEJIE OPTO-ELECT 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.