Violation Code: 476
FDA Violation
Charge Code: NO REGISTR
Violation Details
- Violation Code (ASC ID)
- 476
- Charge Code
- NO REGISTR
- Description
- 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).
- Legal Section
- 536(a); Failure to file initial report
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Pioneer International Latin American S.A | Panama, PANAMA | 46 |
| 2 | Coretronic Projection (Kunshan) Corporation | Kunshan, CHINA | 37 |
| 3 | Panasonic Industry Of Asia | Singapore, SINGAPORE | 31 |
| 4 | LYMA LIFE LTD | London, UNITED KIN | 26 |
| 5 | Energy Tech Development Company | Shanghai, CHINA | 26 |
| 6 | Dongbu Daewoo Electronics Caribbean Inc | Doral, UNITED STA | 23 |
| 7 | Teletronica S A De C V | Tijuana, MEXICO | 23 |
| 8 | Panasonic Logistics (Hong Kong) | Tsim Sha Tsui, HONG KONG | 21 |
| 9 | Zegna-Daidong Limited | Kowloon Bay, HONG KONG | 21 |
| 10 | Edwards Lifesciences Ag | Rio Haina, DOMINICAN | 20 |
| 11 | Olympus Winter & IBE Gmbh | Hamburg, GERMANY | 20 |
| 12 | Celestica (Thailand) Limited | Chonburi, THAILAND | 16 |
| 13 | Toshiba Consumer Products | Jawa Barat, INDONESIA | 15 |
| 14 | UNIQA DENTAL | Netanya, ISRAEL | 15 |
| 15 | M.d. International, Inc. | Doral, UNITED STA | 14 |
| 16 | Sharp Electronics | Mexico, MEXICO | 14 |
| 17 | Laserglow.Com Limited | Toronto, CANADA | 13 |
| 18 | Recycle Generation Co, Ltd. | Hong Kong, CHINA | 12 |
| 19 | Aiwa Latinoamerica Panama) S.A. | Paitilla, PANAMA | 12 |
| 20 | Sherridon Exim Pte Ltd. | Singapore, SINGAPORE | 12 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/26/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | Laytec In-Line GmbhGERMANY |
| 11/24/2025 | ALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS 95RER | JINSOL INDUSTRY CO LTDSOUTH KORE |
| 11/13/2025 | LASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS 95RES | GABARIT LASERFRANCE |
| 11/12/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | Universal Laser SystemsUNITED STA |
| 11/6/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | Universal Laser SystemsUNITED STA |
| 11/3/2025 | OVER-THE-COUNTER COVID-19 ANTIGEN TEST 83QYT | |
| 11/3/2025 | TUBE, ASPIRATING, FLEXIBLE, CONNECTING 80BYY | |
| 11/3/2025 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | Menicon Co., Ltd.JAPAN |
| 10/30/2025 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | ADVANIER LDAPORTUGAL |
| 10/29/2025 | MASSAGER, THERAPEUTIC, ELECTRIC 89ISA | Tricycle LtdSOUTH KORE |
| 10/29/2025 | MASSAGER, THERAPEUTIC, ELECTRIC 89ISA | Tricycle LtdSOUTH KORE |
| 10/27/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | Universal Laser SystemsUNITED STA |
| 10/27/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | TECAN CDMO SOLUTIONS PN SDN BHDMALAYSIA |
| 10/27/2025 | GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL 95RDW | TECAN CDMO SOLUTIONS PN SDN BHDMALAYSIA |
| 10/22/2025 | LASER MARKER OR ENGRAVER 95RHK |
Frequently Asked Questions
What is FDA violation code 476?
476 is an FDA violation code that indicates: "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).". This violation is based on 536(a); Failure to file initial report of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 476?
According to FDA Import Refusal data, there have been 3226 import refusals issued for violation code 476, affecting 2054 unique firms.
When was the most recent refusal for violation 476?
The most recent import refusal for violation 476 was on November 26, 2025.
What products are commonly refused for violation 476?
Products commonly refused under violation 476 include: GENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL, ALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS, 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 476?
Violation code 476 is based on 536(a); Failure to file initial report 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.