Violation Code: 3460
FDA Violation
Charge Code: VIBRIO
Violation Details
- Violation Code (ASC ID)
- 3460
- Charge Code
- VIBRIO
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Vibrio cholerae, a poisonous and deleterious substance which may render it injurious to health.
- Legal Section
- 402(a)(1), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Y.E.S. Export & Import Corporation | Quezon City, PHILIPPINE | 20 |
| 2 | INNOVATIVE FOODS LIMITED | Ezhupunna E D, INDIA | 13 |
| 3 | Global Food Solutions, Incorporated | San Pablo, PHILIPPINE | 5 |
| 4 | VADILAL INDUSTRIES LIMITED | Valsad, INDIA | 3 |
| 5 | Lucky Shing Company Ltd | Long An Province, VIETNAM | 2 |
| 6 | Mofels Food International Corporation | Dasmarinas, PHILIPPINE | 2 |
| 7 | Felmocor Food Processing Corporation | Cavite, PHILIPPINE | 1 |
| 8 | ADF Foods Limited | Nadiad, INDIA | 1 |
| 9 | Pescaderia Alvarez | Hermosillo, MEXICO | 1 |
| 10 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. | Ambernath (E), INDIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 9/5/2025 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT, DRIED OR PASTE 21TGT48 | |
| 9/11/2023 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT PULP 21XGT48 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 9/11/2023 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT PULP 21XGT48 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 8/5/2022 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 8/9/2021 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 7/24/2020 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 6/26/2020 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 5/29/2020 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 5/29/2020 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 5/29/2020 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 3/26/2020 | COCONUT, SHELLED 23BGT05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 1/23/2020 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 1/23/2020 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 12/5/2019 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
| 11/19/2019 | COCONUT, SHELLED 23BGD05 | Y.E.S. Export & Import CorporationPHILIPPINE |
Related Violations
Other violations under the same legal section: 402(a)(1), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3460?
3460 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 contain Vibrio cholerae, a poisonous and deleterious substance which may render it injurious to health.". This violation is based on 402(a)(1), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3460?
According to FDA Import Refusal data, there have been 49 import refusals issued for violation code 3460, affecting 10 unique firms.
When was the most recent refusal for violation 3460?
The most recent import refusal for violation 3460 was on September 5, 2025.
What products are commonly refused for violation 3460?
Products commonly refused under violation 3460 include: COCONUT, SUBTROPICAL AND TROPICAL FRUIT, DRIED OR PASTE, COCONUT, SUBTROPICAL AND TROPICAL FRUIT PULP, COCONUT, SHELLED. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3460?
Violation code 3460 is based on 402(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.