Violation Code: 297
FDA Violation
Charge Code: AFLATOXIN
Violation Details
- Violation Code (ASC ID)
- 297
- Charge Code
- AFLATOXIN
- Description
- The article appears to contain a mycotoxin, 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 | Manzela S.A. De C.V. | Texcoco, MEXICO | 50 |
| 2 | Productos Pepito S.A. de C.V. | Ciudad De Mexico, MEXICO | 39 |
| 3 | Mazapan de la Rosa S.A. de C.V. | Tlajomulco de Zuniga, MEXICO | 35 |
| 4 | Shree Bhagwati Flour & Foods PVT. LTD | Changodar, INDIA | 22 |
| 5 | Olam Orchards Australia Pty Ltd | Teneriffe, AUSTRALIA | 16 |
| 6 | Song NGA Ltd. dba: Sonaco | Ho Chi Minh City, VIETNAM | 15 |
| 7 | Bajaj Food Ltd. | Ahmedabad City, INDIA | 14 |
| 8 | ADANI FOOD PRODUCTS PVT LTD | Rajkot, INDIA | 12 |
| 9 | Manitoba Ltda. | Cali, COLOMBIA | 12 |
| 10 | Naturalsa | Ayutla, MEXICO | 11 |
| 11 | CV.MAKMUR PILAR MAS | Tangerang, INDONESIA | 11 |
| 12 | Productos Avila Sa De Cv | Guadalajara, MEXICO | 11 |
| 13 | Hari Masa S. A de C. V. | Santa Catarina, MEXICO | 10 |
| 14 | Economic Food Solutions Pvt.Ltd. | Cochin, INDIA | 9 |
| 15 | Pepitoria Sinaloense S De Rl De Cv | Guadalajara, MEXICO | 9 |
| 16 | BARCEL, S.A. DE C.V | Pueblo Infonavit Lerma, MEXICO | 8 |
| 17 | ALEJANDRO GARDUNO TORRES | Ciudad De Mexico, MEXICO | 7 |
| 18 | G.F.I. Enterprises, Inc. | Valenzuela, PHILIPPINE | 7 |
| 19 | Productos Y Subproductos, S de RL de CV | Mexicali, MEXICO | 7 |
| 20 | Sahin International Inc | Etobicoke, CANADA | 7 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 7/8/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Exportadora Rio Grande S.A. de C.V.EL SALVADO |
| 6/26/2025 | PISTACHIO, IN SHELL 23AGH11 | |
| 6/26/2025 | PISTACHIO, IN SHELL 23AGH11 | |
| 6/26/2025 | PISTACHIO, IN SHELL 23AGH11 | |
| 6/26/2025 | PISTACHIO, IN SHELL 23AGH11 | |
| 6/26/2025 | PISTACHIO, IN SHELL 23AGH11 | |
| 6/26/2025 | PISTACHIO, IN SHELL 23AGH11 | |
| 6/26/2025 | PISTACHIO, IN SHELL 23AGH11 | |
| 5/7/2025 | PISTACHIO, SHELLED 23BGT11 | |
| 4/18/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Exportadora Rio Grande S.A. de C.V.EL SALVADO |
| 4/18/2025 | CORN, BOLTED MEAL OR FLOUR 02BGT01 | Exportadora Rio Grande S.A. de C.V.EL SALVADO |
| 4/9/2025 | PEANUT, IN SHELL 23AGN07 | KA XING TRADING HONG KONGHONG KONG |
| 4/9/2025 | PEANUT, SHELLED 23BGT07 | KA WING SHENG TRADING LIMITEDHONG KONG |
| 4/9/2025 | PEANUT, SHELLED 23BGT07 | KA WING SHENG TRADING LIMITEDHONG KONG |
| 4/9/2025 | PEANUT, IN SHELL 23AGT07 | KA WING SHENG TRADING LIMITEDHONG KONG |
Related Violations
Other violations under the same legal section: 402(a)(1), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 297?
297 is an FDA violation code that indicates: "The article appears to contain a mycotoxin, 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 297?
According to FDA Import Refusal data, there have been 729 import refusals issued for violation code 297, affecting 252 unique firms.
When was the most recent refusal for violation 297?
The most recent import refusal for violation 297 was on July 8, 2025.
What products are commonly refused for violation 297?
Products commonly refused under violation 297 include: CORN, BOLTED MEAL OR FLOUR, PISTACHIO, IN SHELL. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 297?
Violation code 297 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.