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 |
|---|---|---|
| 1/22/2026 | LASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS 95REU | TECAN CDMO SOLUTIONS PN SDN BHDMALAYSIA |
| 1/22/2026 | LASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS 95REU | TECAN CDMO SOLUTIONS PN SDN BHDMALAYSIA |
| 1/22/2026 | LASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS 95REU | TECAN CDMO SOLUTIONS PN SDN BHDMALAYSIA |
| 1/22/2026 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | AUTOMATED PRECISION INCMOLDOVA |
| 1/21/2026 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | THE CALLIGRAPHY BOXUNITED KIN |
| 1/21/2026 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | WORLD STAR TECHNOLOGIESCANADA |
| 1/16/2026 | UPC READER (BAR CODE RECORDER), UTILITY/PERIPHERAL LASER PRODUCTS 95RFZ | Borries Markier-Systeme GmbhGERMANY |
| 1/12/2026 | SURVEYING LASER PRODUCT, LEVELING, ALIGNMENT LASER PRODUCTS 95REP | HILTI AKTIENGESELLSCHAFTAUSTRIA |
| 1/12/2026 | SURVEYING LASER PRODUCT, LEVELING, ALIGNMENT LASER PRODUCTS 95REP | HILTI AKTIENGESELLSCHAFTAUSTRIA |
| 1/12/2026 | ALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS 95RER | Hillos GmbhGERMANY |
| 1/12/2026 | ALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS 95RER | Hillos GmbhGERMANY |
| 1/12/2026 | ALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS 95RER | Hillos GmbhGERMANY |
| 1/12/2026 | ALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS 95RER | Hillos GmbhGERMANY |
| 1/9/2026 | LED, GENERAL PURPOSE ILLUMINATION, GENERAL OPTICAL PRODUCTS, NON-MEDICAL 95RHH | LLANTRISANT MANUFACTURING PLTUNITED KIN |
| 1/9/2026 | LED, GENERAL PURPOSE ILLUMINATION, GENERAL OPTICAL PRODUCTS, NON-MEDICAL 95RHH | Lufthansa TechnikGERMANY |
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 4700 import refusals issued for violation code 47, affecting 1474 unique firms.
When was the most recent refusal for violation 47?
The most recent import refusal for violation 47 was on January 22, 2026.
What products are commonly refused for violation 47?
Products commonly refused under violation 47 include: LASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS, GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL. 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.