Violation Code: 292

FDA Violation

Charge Code: SUBSTITUTE

Total Refusals

Affected Firms

3/14/2024

Latest Case

4/21/2003

First Case

Violation Details

Violation Code (ASC ID): 292
Charge Code: SUBSTITUTE
Description: It appears to be a drug that a substance has been substituted wholly or in part.
Legal Section: 501(d)(2), 801(a)(3); ADULTERATION

Most Affected Firms

#	Firm Name	Location	Cases
1	Distribuidora Denise Lyda	Belo Orizonte, BRAZIL	11
2	Incredible Products, SA de CV	Guadalajara, MEXICO	10
3	GUANGDONG KEMEI PHARMACEUTICAL TECHNOLOGY CO LTD	Foshan, CHINA	5
4	Maquiladora Miniara SA de CV	Coyotepec, MEXICO	5
5	JG Atlas Comercios, SA de CV	Zapopan, MEXICO	4
6	Albek De Mexico S.A. De C.V.	San Juan Del Rio, MEXICO	4
7	Laboratorios Jaloma S.A. de C.V.	Guadalajara, MEXICO	4
8	Sion Biotext Medical Ltd.	Sderot, ISRAEL	4
9	Broncolin, S.A. de C.V.	Ciudad De Mexico, MEXICO	3
10	SCK Zeta Dis Ticaret Pazarlama Limited Sirketi	Istanbul, TURKEY	3
11	Limpo Quimicos, SA de CV	Escobedo, MEXICO	3
12	AAA Cosmetica, SA de CV	Tlalnepantla, MEXICO	2
13	Glanbia Performance Nutrition, Inc	Sunrise, UNITED STA	2
14	Nouvelle Parfumerie Gandour Cote Di	Abidjan, IVORY COAS	1
15	GL Biochem (Shanghai) Ltd	Shanghai, CHINA	1
16	Botanicals Internacional S.A. de C.V.	Cuautitlan Izcalli, MEXICO	1
17	Nanomateriales, SA de CV	Apodaca, MEXICO	1
18	Liq-E S.A. De C.V.	San Nicolas De Los Garza, MEXICO	1
19	ASM Aerosol Service AG	Mohlin, SWITZERLAN	1
20	HARMONIC NATURE S DE RL MI	Guadalupe, MEXICO	1

Recent Import Refusals

Date	Product	Firm
3/14/2024	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06	Incredible Products, SA de CVMEXICO
3/14/2024	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06	Incredible Products, SA de CVMEXICO
3/14/2024	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06	Incredible Products, SA de CVMEXICO
9/7/2023	SUPPRESSANT N.E.C. 66FDY99	Laboratorios Jaloma S.A. de C.V.MEXICO
3/3/2022	ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05	HARMONIC NATURE S DE RL MIMEXICO
2/17/2022	ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05	Laboratorios Jaloma S.A. de C.V.MEXICO
2/17/2022	ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05	Laboratorios Jaloma S.A. de C.V.MEXICO
2/17/2022	ETHYL ALCOHOL (ANTI-MICROBIAL) 62HAL05	Laboratorios Jaloma S.A. de C.V.MEXICO
9/1/2021	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06	Incredible Products, SA de CVMEXICO
9/1/2021	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06	Incredible Products, SA de CVMEXICO
9/1/2021	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06	Incredible Products, SA de CVMEXICO
9/1/2021	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06	Incredible Products, SA de CVMEXICO
6/22/2021	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06	Incredible Products, SA de CVMEXICO
6/22/2021	SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) 53ED06	Incredible Products, SA de CVMEXICO
6/9/2021	ETHYL ALCOHOL (ANTI-MICROBIAL) 62HBY05	AAA Cosmetica, SA de CVMEXICO

Frequently Asked Questions

What is FDA violation code 292?

292 is an FDA violation code that indicates: "It appears to be a drug that a substance has been substituted wholly or in part.". This violation is based on 501(d)(2), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 292?

According to FDA Import Refusal data, there have been 77 import refusals issued for violation code 292, affecting 30 unique firms.

When was the most recent refusal for violation 292?

The most recent import refusal for violation 292 was on March 14, 2024.

What products are commonly refused for violation 292?

Products commonly refused under violation 292 include: SHAMPOOS (HAIR PREPARATIONS, NON-COLORING), SUPPRESSANT N.E.C., ETHYL ALCOHOL (ANTI-MICROBIAL). These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 292?

Violation code 292 is based on 501(d)(2), 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.