Violation Code: 479
FDA Violation
Charge Code: DV QUALITY
Violation Details
- Violation Code (ASC ID)
- 479
- Charge Code
- DV QUALITY
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
- Legal Section
- 501(c); 801(a)(3) Adulteration
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/12/2025 | FORCEPS, GENERAL & PLASTIC SURGERY 79GEN | |
| 12/5/2025 | SCISSORS, GENERAL USE, SURGICAL 79LRW | |
| 12/5/2025 | HOOK, SURGICAL, GENERAL & PLASTIC SURGERY 79GDG | |
| 12/3/2025 | FORCEPS, GENERAL & PLASTIC SURGERY 79GEN | |
| 11/17/2025 | FORCEPS, GENERAL & PLASTIC SURGERY 79GEN | |
| 10/21/2025 | ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE 73CCK | |
| 9/15/2025 | TAPE AND BANDAGE, ADHESIVE 79KGX | |
| 9/2/2025 | SNARE, FLEXIBLE 78FDI | |
| 9/2/2025 | SNARE, FLEXIBLE 78FDI | |
| 9/2/2025 | SNARE, FLEXIBLE 78FDI | |
| 9/2/2025 | SCISSORS, GENERAL USE, SURGICAL 79LRW | |
| 9/2/2025 | FORCEPS, GENERAL & PLASTIC SURGERY 79GEN | |
| 8/27/2025 | CATHETER, RETENTION TYPE, BALLOON 78EZL | Teleflex Medical Sdn. Bhd.MALAYSIA |
| 8/26/2025 | SNARE, FLEXIBLE 78FDI | |
| 7/15/2025 | SNARE, FLEXIBLE 78FDI |
Related Violations
Other violations under the same legal section: 501(c); 801(a)(3) Adulteration
Frequently Asked Questions
What is FDA violation code 479?
479 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 be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.". This violation is based on 501(c); 801(a)(3) Adulteration of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 479?
According to FDA Import Refusal data, there have been 1383 import refusals issued for violation code 479, affecting 247 unique firms.
When was the most recent refusal for violation 479?
The most recent import refusal for violation 479 was on December 12, 2025.
What products are commonly refused for violation 479?
Products commonly refused under violation 479 include: FORCEPS, GENERAL & PLASTIC SURGERY, SCISSORS, GENERAL USE, SURGICAL, HOOK, SURGICAL, GENERAL & PLASTIC SURGERY. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 479?
Violation code 479 is based on 501(c); 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.