Violation Code: 3725
FDA Violation
Charge Code: NONCOMELT
Violation Details
- Violation Code (ASC ID)
- 3725
- Charge Code
- NONCOMELT
- Description
- It appears that the article is an electronic product which fails to comply with one or more applicable standards prescribed under section 534.
- Legal Section
- 534, 536(a)
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | SHANGHAI SISHUN MACHINERY CO., LIMITED | Shanghai, CHINA | 2 |
| 2 | WUHAN CHUTIAN INDUSTRIAL LASER E | Wuhan, CHINA | 1 |
| 3 | DONGGUAN LOSPEED LASER TECHNOLOGY CO.,LTD | Doongguan, CHINA | 1 |
| 4 | JINAN JINSHIKE CNC EQUIPMENT CO., LTD | Jinan, CHINA | 1 |
| 5 | SHENZHEN TRONXY TECHNOLOGY CO.,LTD | Shenzhen, CHINA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 6/28/2021 | LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS 95RFE | |
| 6/9/2021 | LASER MARKER OR ENGRAVER 95RHK | |
| 10/14/2020 | LASER WELDER, MATERIALS PROCESSING LASER PRODUCTS 95RFF | |
| 10/5/2020 | SURVEYING LASER PRODUCT, LEVELING, ALIGNMENT LASER PRODUCTS 95REP | |
| 7/9/2019 | LASER MARKER OR ENGRAVER 95RHK | |
| 7/3/2019 | LASER MARKER OR ENGRAVER 95RHK |
Related Violations
Other violations under the same legal section: 534, 536(a)
| Code | Charge Code | Cases |
|---|---|---|
| 3726 | ELTNOCERT | 0 |
Frequently Asked Questions
What is FDA violation code 3725?
3725 is an FDA violation code that indicates: "It appears that the article is an electronic product which fails to comply with one or more applicable standards prescribed under section 534.". This violation is based on 534, 536(a) of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3725?
According to FDA Import Refusal data, there have been 6 import refusals issued for violation code 3725, affecting 5 unique firms.
When was the most recent refusal for violation 3725?
The most recent import refusal for violation 3725 was on June 28, 2021.
What products are commonly refused for violation 3725?
Products commonly refused under violation 3725 include: LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS, LASER MARKER OR ENGRAVER, LASER WELDER, MATERIALS PROCESSING LASER PRODUCTS, SURVEYING LASER PRODUCT, LEVELING, ALIGNMENT LASER PRODUCTS. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3725?
Violation code 3725 is based on 534, 536(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This section of the law establishes requirements that imported products must meet to be allowed entry into the United States.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.