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Violation Code: 297

FDA Violation

Charge Code: AFLATOXIN

731
Total Refusals
253
Affected Firms
1/15/2026
Latest Case
10/15/2001
First Case

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 NameLocationCases
1Manzela S.A. De C.V.Texcoco, MEXICO50
2Productos Pepito S.A. de C.V.Ciudad De Mexico, MEXICO39
3Mazapan de la Rosa S.A. de C.V.Tlajomulco de Zuniga, MEXICO35
4Shree Bhagwati Flour & Foods PVT. LTDChangodar, INDIA22
5Olam Orchards Australia Pty LtdTeneriffe, AUSTRALIA16
6Song NGA Ltd. dba: SonacoHo Chi Minh City, VIETNAM15
7Bajaj Food Ltd.Ahmedabad City, INDIA14
8ADANI FOOD PRODUCTS PVT LTDRajkot, INDIA12
9Manitoba Ltda.Cali, COLOMBIA12
10NaturalsaAyutla, MEXICO11
11CV.MAKMUR PILAR MASTangerang, INDONESIA11
12Productos Avila Sa De CvGuadalajara, MEXICO11
13Hari Masa S. A de C. V.Santa Catarina, MEXICO10
14Economic Food Solutions Pvt.Ltd.Cochin, INDIA9
15Pepitoria Sinaloense S De Rl De CvGuadalajara, MEXICO9
16BARCEL, S.A. DE C.VPueblo Infonavit Lerma, MEXICO8
17G.F.I. Enterprises, Inc.Valenzuela, PHILIPPINE7
18Exportadora Rio Grande S.A. de C.V.San Martin, EL SALVADO7
19Sahin International IncEtobicoke, CANADA7
20Productos Y Subproductos, S de RL de CVMexicali, MEXICO7

Recent Import Refusals

DateProductFirm
1/15/2026
PEANUT, SHELLED
23BHT07
12/10/2025
CORN, BOLTED MEAL OR FLOUR
02BGT01
7/8/2025
CORN, BOLTED MEAL OR FLOUR
02BGT01
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
4/18/2025
CORN, BOLTED MEAL OR FLOUR
02BGT01
4/9/2025
PEANUT, IN SHELL
23AGN07
4/9/2025
PEANUT, SHELLED
23BGT07

Related Violations

Other violations under the same legal section: 402(a)(1), 801(a)(3); ADULTERATION

CodeCharge CodeCases
9SALMONELLA23424
251POISONOUS5009
295LISTERIA3207
281BACTERIA487
3878POISONORD377
245EXCESS SUL142
3897MYCOTOXIN54
3460VIBRIO49

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 731 import refusals issued for violation code 297, affecting 253 unique firms.

When was the most recent refusal for violation 297?

The most recent import refusal for violation 297 was on January 15, 2026.

What products are commonly refused for violation 297?

Products commonly refused under violation 297 include: PEANUT, SHELLED, 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.