Violation Code: 278
FDA Violation
Charge Code: NO TAG
Violation Details
- Violation Code (ASC ID)
- 278
- Charge Code
- NO TAG
- 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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
- Legal Section
- 536(a),(b); NOT CERTIFIED
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/19/2025 | LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS 95RFE | |
| 11/6/2025 | POWERED LASER SURGICAL INSTRUMENTS 79GEX | |
| 10/22/2025 | LASER MARKER OR ENGRAVER 95RHK | |
| 10/22/2025 | ALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS 95RER | Grupo Corpesa Sa De CvMEXICO |
| 9/17/2025 | LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS 95RFE | |
| 9/10/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | |
| 9/10/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | |
| 8/13/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | Sikora AgGERMANY |
| 8/8/2025 | LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS 95RFE | |
| 6/13/2025 | LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS 95RFE | BERGFELD LASERTECH GMBHGERMANY |
| 5/13/2025 | LASER MARKER OR ENGRAVER 95RHK | |
| 4/11/2025 | LASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS 95RES | |
| 4/9/2025 | POWERED LASER SURGICAL INSTRUMENTS 79GEX | TRIANGEL RSD LIMITEDCHINA |
| 4/2/2025 | LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS 95RFE | |
| 3/31/2025 | LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS 95RFE |
Frequently Asked Questions
What is FDA violation code 278?
278 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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).". This violation is based on 536(a),(b); NOT CERTIFIED of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 278?
According to FDA Import Refusal data, there have been 566 import refusals issued for violation code 278, affecting 282 unique firms.
When was the most recent refusal for violation 278?
The most recent import refusal for violation 278 was on December 19, 2025.
What products are commonly refused for violation 278?
Products commonly refused under violation 278 include: LASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS, POWERED LASER SURGICAL INSTRUMENTS, LASER MARKER OR ENGRAVER, ALIGNMENT LASER PRODUCT, 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 278?
Violation code 278 is based on 536(a),(b); NOT CERTIFIED 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.