Violation Code: 472
FDA Violation
Charge Code: NO ENGLISH
Violation Details
- Violation Code (ASC ID)
- 472
- Charge Code
- NO ENGLISH
- Description
- Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
- Legal Section
- 502(c); 801(a)(3) ;MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Best-pharm Ltd. | Moscow, RUSSIA | 105 |
| 2 | Farm Invest | M. Chernivtsi, UKRAINE | 85 |
| 3 | Fu Sung Pharmaceutaical Works | Unknown, CHINA | 52 |
| 4 | Productos Medline, S.A. de C.V. | Nuevo Laredo, MEXICO | 47 |
| 5 | MARTINEZ ENVIOS EXPRESS 504 | Juticalpa, HONDURAS | 32 |
| 6 | Wyeth Ilaclari As | Esentepe Istanbul, TURKEY | 31 |
| 7 | Bio Fresh Ltd. | Plovdiv, BULGARIA | 30 |
| 8 | Dr Irena Eris S.A. | Piaseczno, POLAND | 26 |
| 9 | Centro Botanico Azteca SA | Mexico, MEXICO | 23 |
| 10 | OMEGA NUTRITION | Hidalgo Del Parral, MEXICO | 22 |
| 11 | Enrique Ordoqui Pose | Montevideo, URUGUAY | 21 |
| 12 | Beiersdorf AG | Hamburg, GERMANY | 21 |
| 13 | PHARM-INVEST JV | Chernovcy-Chemihivska, UKRAINE | 21 |
| 14 | Best Pharm | Moscow, RUSSIA | 21 |
| 15 | Mineralbio Co Ltd | Seongnam, SOUTH KORE | 20 |
| 16 | Guangzhou Youxi Cosmetics Co. Ltd. | Guangzhou, CHINA | 19 |
| 17 | CADBURY ADAMS MEXICO, S DE R.L. DE C.V. | Delg Cuajimalpa De Morelos, MEXICO | 18 |
| 18 | E-Pharma Trento SPA | Trento, ITALY | 17 |
| 19 | Lab Por | Are, PERU | 16 |
| 20 | Allergan Pharmaceuticals Ireland | Westport, IRELAND | 16 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | ONABOTULINUMTOXINA 58PCZ05 | Merz Pharma GmbH & Co., KGaAGERMANY |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBA01 | Haleon US Holdings LLCUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBA01 | OPMX LLC HEALTHUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBA01 | Akron Pharma, Inc.UNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | Haleon US Holdings LLCUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | Haleon US Holdings LLCUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | Haleon US Holdings LLCUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | Haleon US Holdings LLCUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | Haleon US Holdings LLCUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | ELLA DEMCHUK C/O AMAZON.COM FBAUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | OPMX LLC HEALTHUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | OPMX LLC HEALTHUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | Dollar General CorporationUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | Dollar General CorporationUNITED STA |
| 1/15/2026 | ACETAMINOPHEN (ANALGESIC) 60LBH01 | OPMX LLC HEALTHUNITED STA |
Related Violations
Other violations under the same legal section: 502(c); 801(a)(3) ;MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 3870 | 708NOENGL | 4 |
Frequently Asked Questions
What is FDA violation code 472?
472 is an FDA violation code that indicates: "Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).". This violation is based on 502(c); 801(a)(3) ;MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 472?
According to FDA Import Refusal data, there have been 3640 import refusals issued for violation code 472, affecting 1742 unique firms.
When was the most recent refusal for violation 472?
The most recent import refusal for violation 472 was on January 22, 2026.
What products are commonly refused for violation 472?
Products commonly refused under violation 472 include: ONABOTULINUMTOXINA, ACETAMINOPHEN (ANALGESIC). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 472?
Violation code 472 is based on 502(c); 801(a)(3) ;MISBRANDING 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.