Violation Code: 47
FDA Violation
Charge Code: NON STD
Violation Details
- Violation Code (ASC ID)
- 47
- Charge Code
- NON STD
- Description
- 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.
- Legal Section
- 536(a),(b); NON STANDARD
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/19/2025 | LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS 95RFE | |
| 12/5/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | MSS LASERSUNITED KIN |
| 11/26/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | Laytec In-Line GmbhGERMANY |
| 11/21/2025 | LASER MARKER OR ENGRAVER 95RHK | ZIOU KOREASOUTH KORE |
| 11/13/2025 | LASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS 95RES | GABARIT LASERFRANCE |
| 11/12/2025 | LASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS 95REU | TECAN CDMO SOLUTIONS PN SDN. BHDMALAYSIA |
| 11/12/2025 | LASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS 95REU | TECAN CDMO SOLUTIONS PN SDN. BHDMALAYSIA |
| 11/10/2025 | REMOTE CONTROLLER, LASER, DATA MEASUREMENT, TRANSMIT 95RFP | UNFOLDED CIRCLE APSDENMARK |
| 11/10/2025 | REMOTE CONTROLLER, LASER, DATA MEASUREMENT, TRANSMIT 95RFP | UNFOLDED CIRCLE APSDENMARK |
| 11/10/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | |
| 11/10/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | |
| 10/31/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | HONG KONG GUANGCHI TRADING CO.,LTDHONG KONG |
| 10/28/2025 | RESEARCH LASER, SCIENTIFIC, LABORATORY LASER PRODUCTS 95REK | BOGDANUNITED KIN |
| 10/28/2025 | ALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS 95RER | ENGINEERING CPR, INC.CANADA |
| 10/16/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW |
Frequently Asked Questions
What is FDA violation code 47?
47 is an FDA violation code that indicates: "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.". This violation is based on 536(a),(b); NON STANDARD of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 47?
According to FDA Import Refusal data, there have been 4683 import refusals issued for violation code 47, affecting 1465 unique firms.
When was the most recent refusal for violation 47?
The most recent import refusal for violation 47 was on December 19, 2025.
What products are commonly refused for violation 47?
Products commonly refused under violation 47 include: LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS, GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL, LASER MARKER OR ENGRAVER, LASER POINTER, SURVEYING, 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 47?
Violation code 47 is based on 536(a),(b); NON STANDARD 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.