Changzhou Huada Kejie Opto-Electro Instrument Co., Ltd
⚠️ Moderate Risk
FEI: 3008116228 • Changzhou, Jiangsu • CHINA
FEI Number
3008116228
Location
Changzhou, Jiangsu
Country
CHINAAddress
NO. 16 Beigangjiedao Zhonglou, Jingjikaifaqu Meihualu, Changzhou, Jiangsu, 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 |
|---|---|---|---|
| 6/12/2015 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Changzhou Huada Kejie Opto-Electro Instrument Co., Ltd's FDA import refusal history?
Changzhou Huada Kejie Opto-Electro Instrument Co., Ltd (FEI: 3008116228) has 1 FDA import refusal record(s) in our database, spanning from 6/12/2015 to 6/12/2015.
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-Electro Instrument Co., Ltd's FEI number is 3008116228.
What types of violations has Changzhou Huada Kejie Opto-Electro Instrument Co., Ltd received?
Changzhou Huada Kejie Opto-Electro Instrument Co., Ltd 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-Electro Instrument Co., Ltd come from?
All FDA import refusal data for Changzhou Huada Kejie Opto-Electro Instrument 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.