Violation Code: 2860

FDA Violation

Charge Code: VETDRUGRES

3,506

Total Refusals

734

Affected Firms

12/30/2025

Latest Case

8/12/2002

First Case

Violation Details

Violation Code (ASC ID): 2860
Charge Code: VETDRUGRES
Description: The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains
Legal Section: 402(a)(2)(C)(ii); 801(a)(3); ADULTERATION

Most Affected Firms

#	Firm Name	Location	Cases
1	Yelin Hoitat Quick Frozen Seafood Co., Ltd.	Yangjiang, CHINA	87
2	Jagadeesh Marine Exports	West Godavari, INDIA	69
3	Shantou Olive Pharmaceutical Co.,Ltd	Shantou, CHINA	57
4	FISHERGOLD COLD STORAGE SDN BHD	Bukit Mertajam, MALAYSIA	54
5	Changle Juquan Foods Co., Ltd.	Fuzhou, CHINA	54
6	Seng Enterprise Seafood Supplier (1986)	George Town, MALAYSIA	49
7	HONG SAN FROZEN FOODS SDN BHD	Seberang Perai Utara, MALAYSIA	42
8	PT Rex Canning	Pasuruan, INDONESIA	40
9	Zhanjiang Guolian Aquatic Products Co., Ltd	Zhanjiang, CHINA	38
10	Shantou Ocean Freezing Industry And Trade Gen. Corp.	Shantou, CHINA	38
11	Quoc Viet Seaproducts Processing Trading & Imp-Exp Co., Ltd	Ca Mau City, VIETNAM	34
12	Xiangjiang Food Co.,Ltd	Ningbo, CHINA	32
13	ASIAN SEAFOODS (ZHANJIANG) CO.,	Zhanjiang, CHINA	32
14	LEAN HENG HUAT FISHERY	Seberang Perai Tengah, MALAYSIA	31
15	Gallant Ocean International Inc	Kaohsiung City, TAIWAN	28
16	Jiangxi Junma Foods Co.,LTD	Shangrao City, CHINA	28
17	Fujian Provincial Mei Hua Aquatic Processing Factory	Meixin, CHINA	27
18	Zhanjiang Longwei Aquatic Products Industry Co., Ltd.	Zhanjiang, CHINA	27
19	SHENGYUAN AQUATIC FOOD CO.,LTD.NINGDE FUJIAN	Ningde, CHINA	24
20	PUJIANG FREEZING FACTORY OF XIAMEN XIANGAN	Xiamen, CHINA	24

Recent Import Refusals

Date	Product	Firm
12/30/2025	SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS 16XGT21	NEKKANTI MEGA FOOD PARK PRIVATE LIMITED-UNIT#1INDIA
12/29/2025	SHRIMP & PRAWNS, BREADED 16KGT05	PT. PABRIK LAMONGAN BMIINDONESIA
12/29/2025	SHRIMP & PRAWNS, BREADED 16KGT05	PT. PABRIK LAMONGAN BMIINDONESIA
12/16/2025	SHRIMP & PRAWNS 16JGD05	QINGDAO BEST OCEANS CO.,LTDCHINA
12/10/2025	SHRIMP & PRAWNS 16JYH05	BEH CHIN KOK TRADINGMALAYSIA
12/5/2025	SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS 16XGT21	PT. PABRIK LAMONGAN BMIINDONESIA
11/26/2025	SHRIMP & PRAWNS 16JYH05	TEE CHING KIATMALAYSIA
11/19/2025	CROAKER 16AGD13	Ningde Wanxing Food Co.,Ltd.CHINA
11/13/2025	SHRIMP & PRAWNS, BREADED 16KGD05	Gallant Dachan Seafood Co., Ltd.VIETNAM
11/6/2025	SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS 16XGT21	Sandhya Aqua Exports Pvt Ltd Unit 2INDIA
10/30/2025	SHRIMP & PRAWNS, BREADED 16KGT05	PT. PABRIK LAMONGAN BMIINDONESIA
10/22/2025	DACE, CAKES, BALLS, ETC. 16CGT57	YIXIAN FOOD FACTORY OF ZHONGSHANCHINA
10/22/2025	DACE, CAKES, BALLS, ETC. 16CGT57	YIXIAN FOOD FACTORY OF ZHONGSHANCHINA
10/20/2025	SHRIMP & PRAWNS, BREADED 16KGT05	PT. Tamron Akuatik Produk IndustriINDONESIA
10/20/2025	SHRIMP & PRAWNS, BREADED 16KGT05	PT. Tamron Akuatik Produk IndustriINDONESIA

Frequently Asked Questions

What is FDA violation code 2860?

2860 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 contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains". This violation is based on 402(a)(2)(C)(ii); 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.

How many import refusals have been issued for violation 2860?

According to FDA Import Refusal data, there have been 3506 import refusals issued for violation code 2860, affecting 734 unique firms.

When was the most recent refusal for violation 2860?

The most recent import refusal for violation 2860 was on December 30, 2025.

What products are commonly refused for violation 2860?

Products commonly refused under violation 2860 include: SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, SHRIMP & PRAWNS, BREADED, SHRIMP & PRAWNS. These products were refused entry because they did not meet FDA requirements.

What is the legal basis for FDA violation code 2860?

Violation code 2860 is based on 402(a)(2)(C)(ii); 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.