Canon Zhuhai, Inc.
⚠️ High Risk
FEI: 3002495897 • Guang Dong • CHINA
FEI Number
3002495897
Location
Guang Dong
Country
CHINAAddress
A-1 Beiling Industrial District, , Guang Dong, , China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/28/2004 | 95L30LASER PRINTERS | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/26/2004 | 95L30LASER PRINTERS | 47NON STD | Florida District Office (FLA-DO) |
| 11/25/2003 | 95L30LASER PRINTERS | 47NON STD | Florida District Office (FLA-DO) |
| 10/21/2003 | 95L30LASER PRINTERS | 47NON STD | Florida District Office (FLA-DO) |
| 9/10/2003 | 95L30LASER PRINTERS | 47NON STD | Florida District Office (FLA-DO) |
| 9/10/2003 | 95L30LASER PRINTERS | 47NON STD | Florida District Office (FLA-DO) |
| 9/10/2003 | 95L30LASER PRINTERS | 47NON STD | Florida District Office (FLA-DO) |
| 9/10/2003 | 95L30LASER PRINTERS | 47NON STD | Florida District Office (FLA-DO) |
| 9/9/2003 | 95L30LASER PRINTERS | 47NON STD | Florida District Office (FLA-DO) |
| 9/8/2003 | 95L30LASER PRINTERS | 126FAILS STD | Florida District Office (FLA-DO) |
| 7/29/2003 | 95L30LASER PRINTERS | 47NON STD | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Canon Zhuhai, Inc.'s FDA import refusal history?
Canon Zhuhai, Inc. (FEI: 3002495897) has 11 FDA import refusal record(s) in our database, spanning from 7/29/2003 to 1/28/2004.
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. Canon Zhuhai, Inc.'s FEI number is 3002495897.
What types of violations has Canon Zhuhai, Inc. received?
Canon Zhuhai, Inc. 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 Canon Zhuhai, Inc. come from?
All FDA import refusal data for Canon Zhuhai, Inc. 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.