Violation Code: 304
FDA Violation
Charge Code: STERILITY
Violation Details
- Violation Code (ASC ID)
- 304
- Charge Code
- STERILITY
- Description
- The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
- Legal Section
- 501(a)(1), 801(a)(3); ADULTERATION
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 9/24/2025 | FIRST AID KIT WITHOUT DRUG 79OHO | |
| 9/24/2025 | BURN KIT WITHOUT DRUG 79OJJ | |
| 9/15/2025 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 6/9/2025 | BANDAGE, ELASTIC 80FQM | |
| 6/9/2025 | KIT, FIRST AID 79LRR | |
| 11/7/2024 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 11/7/2024 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 11/7/2024 | FIRST AID KIT WITHOUT DRUG 79OHO | |
| 10/24/2024 | EMERGENCY RESPONSE SAFETY KIT 80OKI | |
| 10/8/2024 | BANDAGE, ELASTIC 80FQM | |
| 9/9/2024 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 9/9/2024 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 7/29/2024 | KIT, FIRST AID 79LRR | |
| 7/29/2024 | KIT, FIRST AID 79LRR | |
| 7/29/2024 | KIT, FIRST AID 79LRR |
Frequently Asked Questions
What is FDA violation code 304?
304 is an FDA violation code that indicates: "The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.". This violation is based on 501(a)(1), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 304?
According to FDA Import Refusal data, there have been 48 import refusals issued for violation code 304, affecting 23 unique firms.
When was the most recent refusal for violation 304?
The most recent import refusal for violation 304 was on September 24, 2025.
What products are commonly refused for violation 304?
Products commonly refused under violation 304 include: FIRST AID KIT WITHOUT DRUG, BURN KIT WITHOUT DRUG, TAPE AND BANDAGE, ADHESIVE, BANDAGE, ELASTIC, KIT, FIRST AID. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 304?
Violation code 304 is based on 501(a)(1), 801(a)(3); ADULTERATION 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.