Violation Code: 281

FDA Violation

Charge Code: BACTERIA

483

Total Refusals

262

Affected Firms

6/16/2025

Latest Case

10/5/2001

First Case

Violation Details

Violation Code (ASC ID): 281
Charge Code: BACTERIA
Description: The article appears to contain a poisonous and deleterious substance which may render it injurious to health. Contains
Legal Section: 402(a)(1), 801(a)(3); ADULTERATION

Most Affected Firms

#	Firm Name	Location	Cases
1	Cooperativa de Servicio y Credito para la Produccion Agropecuaria Masiguito R.L.	Camoapa, NICARAGUA	19
2	Cooperativa de Servicios para la Produccion Agropecuaria San Francisco de Asis R.L.	Camoapa, NICARAGUA	14
3	Golden Hands Manufacturing Corporation	Malabon, PHILIPPINE	12
4	Clipper Seafood De Venezuela Ca	La Canada De Urdaneta, VENEZUELA	11
5	PANADERIA Y LACTEOS LA VENTA	Tegucigalpa, HONDURAS	9
6	Productos Lacteos Hacienda Agua Blanca SC de RL de CV	Tepatitlan de Morelos, MEXICO	8
7	Ocampo Lozano Ismael	Huitzuco. Gro, MEXICO	7
8	Bufalabella S.A.S.	Bogota, COLOMBIA	7
9	Queseria Dos Lagunas S. de P.R.	Cd. Juarez, MEXICO	7
10	Lacteos Don Chente S.A. de C.V.	Ciudad Juarez, MEXICO	6
11	Productos Nica	Managua, NICARAGUA	6
12	Lacteos Matiguas & Cia Limitada	Matiguas, NICARAGUA	6
13	Cooperativa Colanta Ltda.	Medellin, COLOMBIA	5
14	Sori' Italia SRL	Teano, ITALY	5
15	Productos Naver	Comayaguela, HONDURAS	5
16	Exportadora De Productos Mexicanos	Las Choapas, MEXICO	5
17	Perrin-Vermot SA	Cleron, FRANCE	5
18	BEPPINO OCCELLI AGRINATURA	Farigliano, ITALY	5
19	Caseificio Antichi Sapori	Padula, ITALY	4
20	Productos Lacteos Matiguas Y Cia	Matiguas, NICARAGUA	4

Recent Import Refusals

Date	Product	Firm
6/16/2025	FACE MAKEUP KITS (MAKEUP PREPARATIONS, NOT FOR EYES) 53GH09	Baoding Habo Arts and Crafts Manufacturing Co., Ltd..CHINA
2/21/2025	CHEESE AND CHEESE PRODUCTS, NOT ELSEWHERE MENTIONED, N.E.C. 12YFT99	Cooperativa de Servicio y Credito para la Produccion Agropecuaria Masiguito R.L.NICARAGUA
10/26/2023	CHEESE, CHEESE, PASTEURIZED, PROCESSED WITH FRUIT, VEGETABLES OR MEATS (STANDARDIZED) 12BGT08	LACTEOS LANDAVERDE LOS RODRIGUEZEL SALVADO
10/26/2023	CHEESE, SPICED (STANDARDIZED) 12AGT57	QUESOS PETACONESEL SALVADO
10/26/2023	CHEESE AND CHEESE PRODUCTS, NOT ELSEWHERE MENTIONED, N.E.C. 12YGP99	QUESOS PETACONESEL SALVADO
8/1/2022	ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) 54FBA94	Marudhar ImpexINDIA
8/1/2022	VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YYY99	Marudhar ImpexINDIA
8/1/2022	VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YYY99	Marudhar ImpexINDIA
7/29/2022	VITAMIN, N.E.C. 54ACR99	HERBAFOOD SA DE CVMEXICO
6/2/2022	ASHWAGANDHA (HERBAL & BOTANICALS, NOT TEAS) 54FBY94	Marudhar ImpexINDIA
12/7/2021	SESAME PASTE 37KHT21	Achdut factory for tahini halva and sweetsISRAEL
10/12/2021	CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) 12AGT19	Agroindustrias Lacteas Los Quesos De Oriente S.A. de C.V.EL SALVADO
8/20/2021	CILANTRO (LEAF & STEM VEGETABLE) 24TGC46	RANCHO LOS ABRIOJOSMEXICO
2/17/2021	MILK PROTEIN CONCENTRATE 09DFH32	MILK SPECIALTIESUNITED STA
3/31/2020	CHEESE, HISPANIC/LATINO/MEXICAN STYLE, ALL VARIETIES, INCLUDING QUESO 12CVC13	Quesos PersaMEXICO

Related Violations

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

Code	Charge Code	Cases
9	SALMONELLA	23378
251	POISONOUS	4971
295	LISTERIA	3187
297	AFLATOXIN	729
3878	POISONORD	374
245	EXCESS SUL	142
3897	MYCOTOXIN	54
3460	VIBRIO	49

Frequently Asked Questions

What is FDA violation code 281?

281 is an FDA violation code that indicates: "The article appears to contain a poisonous and deleterious substance which may render it injurious to health. 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 281?

According to FDA Import Refusal data, there have been 483 import refusals issued for violation code 281, affecting 262 unique firms.

When was the most recent refusal for violation 281?

The most recent import refusal for violation 281 was on June 16, 2025.

What products are commonly refused for violation 281?

Products commonly refused under violation 281 include: FACE MAKEUP KITS (MAKEUP PREPARATIONS, NOT FOR EYES), CHEESE AND CHEESE PRODUCTS, NOT ELSEWHERE MENTIONED, N.E.C., CHEESE, CHEESE, PASTEURIZED, PROCESSED WITH FRUIT, VEGETABLES OR MEATS (STANDARDIZED), CHEESE, SPICED (STANDARDIZED). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 281?

Violation code 281 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.