Changchun New Industries Optoelectronics Tech. Co., Ltd.
⚠️ High Risk
FEI: 3002756898 • Changchun, Jilin • CHINA
FEI Number
3002756898
Location
Changchun, Jilin
Country
CHINAAddress
NO. 888 Jinhu Road, HIGH-TECH ZONE, Changchun, Jilin, 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
NO TAG
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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
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.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/18/2024 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Division of Southeast Imports (DSEI) | |
| 8/2/2024 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Division of Northern Border Imports (DNBI) | |
| 8/2/2024 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Division of Northern Border Imports (DNBI) | |
| 4/30/2024 | 95REKRESEARCH LASER, SCIENTIFIC, LABORATORY LASER PRODUCTS | 47NON STD | Division of Northeast Imports (DNEI) |
| 8/18/2023 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Division of Southeast Imports (DSEI) | |
| 7/27/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 278NO TAG | Division of Southeast Imports (DSEI) |
| 7/27/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 278NO TAG | Division of Southeast Imports (DSEI) |
| 7/27/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 278NO TAG | Division of Southeast Imports (DSEI) |
| 7/27/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 278NO TAG | Division of Southeast Imports (DSEI) |
| 7/27/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 278NO TAG | Division of Southeast Imports (DSEI) |
| 7/27/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 278NO TAG | Division of Southeast Imports (DSEI) |
| 7/27/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 278NO TAG | Division of Southeast Imports (DSEI) |
| 7/27/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 278NO TAG | Division of Southeast Imports (DSEI) |
| 7/27/2018 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 278NO TAG | Division of Southeast Imports (DSEI) |
| 11/18/2015 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Seattle District Office (SEA-DO) | |
| 9/4/2015 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Seattle District Office (SEA-DO) | |
| 11/7/2014 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Seattle District Office (SEA-DO) | |
| 12/2/2013 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 476NO REGISTR | New Orleans District Office (NOL-DO) |
| 8/28/2013 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | Cincinnati District Office (CIN-DO) |
| 1/10/2008 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Chicago District Office (CHI-DO) |
| 10/10/2007 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Chicago District Office (CHI-DO) | |
| 8/1/2005 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Changchun New Industries Optoelectronics Tech. Co., Ltd.'s FDA import refusal history?
Changchun New Industries Optoelectronics Tech. Co., Ltd. (FEI: 3002756898) has 22 FDA import refusal record(s) in our database, spanning from 8/1/2005 to 11/18/2024.
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. Changchun New Industries Optoelectronics Tech. Co., Ltd.'s FEI number is 3002756898.
What types of violations has Changchun New Industries Optoelectronics Tech. Co., Ltd. received?
Changchun New Industries Optoelectronics Tech. Co., Ltd. has been cited for 5 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 Changchun New Industries Optoelectronics Tech. Co., Ltd. come from?
All FDA import refusal data for Changchun New Industries Optoelectronics Tech. 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.