Violation Code: 3897
FDA Violation
Charge Code: MYCOTOXIN
Violation Details
- Violation Code (ASC ID)
- 3897
- Charge Code
- MYCOTOXIN
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous and deleterious substance, namely a mycotoxin (aflatoxin, deoxynivalenol, fumonisin, or ochratoxin A), which may render it injurious to health. Bears or contains:
- Legal Section
- 402(a)(1), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Exportadora Rio Grande S.A. de C.V. | San Martin, EL SALVADO | 12 |
| 2 | Fresh and Tasty Farms | Accra, GHANA | 4 |
| 3 | Acceso Peanut Enterprise Corporation, S.A. | Port-Au-Prince, HAITI | 4 |
| 4 | KIRLIOGLU TARIM URUNLERI TICARET LIMITED SIRKETI | Aydin, TURKEY | 4 |
| 5 | MARIA HERNANDEZ | Santa Tecla, EL SALVADO | 3 |
| 6 | ACE FOODS PVT LTD Unit I | Mangalore, INDIA | 3 |
| 7 | HALDIRAM SNACKS PVT. LTD. | Noida, INDIA | 3 |
| 8 | Arizo Zeba LLC | Kabul, AFGHANISTA | 2 |
| 9 | Unique Fragrances | Sonepat, INDIA | 2 |
| 10 | G.F.I. Enterprises, Inc. | Valenzuela, PHILIPPINE | 2 |
| 11 | IZMIR ORGANIK MEYVECILIK SANAYI VE TICARET | Izmir, TURKEY | 2 |
| 12 | Suncity Farms | Deme, GHANA | 1 |
| 13 | Monte Vista Farming Company, LLC | Denair, UNITED STA | 1 |
| 14 | TEJAS FOOD INDUSTRIES LLP | Hyderabad, INDIA | 1 |
| 15 | Cv.Fajar Jaya | North Jakarta, INDONESIA | 1 |
| 16 | Distributions Farinex/113712 Can | Boisbriand, CANADA | 1 |
| 17 | Productos Pepito S.A. de C.V. | Ciudad De Mexico, MEXICO | 1 |
| 18 | Shree Bhagwati Flour & Foods PVT. LTD | Changodar, INDIA | 1 |
| 19 | Euroasias | Mumbai, INDIA | 1 |
| 20 | Wholesome Nut Company | Modesto, UNITED STA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/22/2025 | FIG, DRIED OR PASTE 21TYH03 | |
| 9/17/2025 | MELON SEEDS (EDIBLE SEED) 23KAH05 | |
| 9/17/2025 | MELON SEEDS (EDIBLE SEED) 23KAH05 | |
| 9/17/2025 | MELON SEEDS (EDIBLE SEED) 23KAH05 | |
| 9/17/2025 | MELON SEEDS (EDIBLE SEED) 23KAH05 | |
| 7/30/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Suncity FarmsGHANA |
| 6/27/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Exportadora Rio Grande S.A. de C.V.EL SALVADO |
| 6/10/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Exportadora Rio Grande S.A. de C.V.EL SALVADO |
| 5/16/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Exportadora Rio Grande S.A. de C.V.EL SALVADO |
| 5/15/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Exportadora Rio Grande S.A. de C.V.EL SALVADO |
| 5/9/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Exportadora Rio Grande S.A. de C.V.EL SALVADO |
| 5/2/2025 | PEANUT, SHELLED 23BGT07 | |
| 4/10/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Exportadora Rio Grande S.A. de C.V.EL SALVADO |
| 4/10/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Exportadora Rio Grande S.A. de C.V.EL SALVADO |
| 4/9/2025 | ALMOND, SHELLED 23BGH01 | Monte Vista Farming Company, LLCUNITED STA |
Related Violations
Other violations under the same legal section: 402(a)(1), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3897?
3897 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 bear or contain a poisonous and deleterious substance, namely a mycotoxin (aflatoxin, deoxynivalenol, fumonisin, or ochratoxin A), which may render it injurious to health. Bears or contains:". 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 3897?
According to FDA Import Refusal data, there have been 54 import refusals issued for violation code 3897, affecting 24 unique firms.
When was the most recent refusal for violation 3897?
The most recent import refusal for violation 3897 was on December 22, 2025.
What products are commonly refused for violation 3897?
Products commonly refused under violation 3897 include: FIG, DRIED OR PASTE, MELON SEEDS (EDIBLE SEED). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3897?
Violation code 3897 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.