Violation Code: 78
FDA Violation
Charge Code: STERILITY
Violation Details
- Violation Code (ASC ID)
- 78
- Charge Code
- STERILITY
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
- Legal Section
- 501(a)(2)(A), 801(a)(3); ADULTERATION
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 9/9/2025 | BURN KIT WITHOUT DRUG 79OJJ | |
| 9/9/2025 | BANDAGE, ELASTIC 80FQM | |
| 9/9/2025 | BANDAGE, ELASTIC 80FQM | |
| 9/9/2025 | BANDAGE, ELASTIC 80FQM | |
| 5/5/2025 | DRESSING, WOUND, HYDROPHILIC 79NAC | |
| 5/5/2025 | DRESSING, WOUND, HYDROPHILIC 79NAC | |
| 11/12/2024 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 10/9/2024 | FIRST AID KIT WITHOUT DRUG 79OHO | |
| 3/1/2024 | LENSES, SOFT CONTACT, DAILY WEAR 86LPL | GEO Medical Co., Ltd.SOUTH KORE |
| 12/14/2023 | DRESSING, WOUND, HYDROPHILIC 79NAC | |
| 12/14/2023 | BANDAGE, ELASTIC 80FQM | |
| 10/25/2023 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 10/12/2023 | BANDAGE, ELASTIC 80FQM | |
| 10/11/2023 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 8/10/2023 | SNARE, FLEXIBLE 78FDI |
Related Violations
Other violations under the same legal section: 501(a)(2)(A), 801(a)(3); ADULTERATION
| Code | Charge Code | Cases |
|---|---|---|
| 186 | INSANITARY | 282 |
Frequently Asked Questions
What is FDA violation code 78?
78 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.". This violation is based on 501(a)(2)(A), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 78?
According to FDA Import Refusal data, there have been 510 import refusals issued for violation code 78, affecting 85 unique firms.
When was the most recent refusal for violation 78?
The most recent import refusal for violation 78 was on September 9, 2025.
What products are commonly refused for violation 78?
Products commonly refused under violation 78 include: BURN KIT WITHOUT DRUG, BANDAGE, ELASTIC, DRESSING, WOUND, HYDROPHILIC. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 78?
Violation code 78 is based on 501(a)(2)(A), 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.