Violation Code: 3844
FDA Violation
Charge Code: SACCHARLBL
Violation Details
- Violation Code (ASC ID)
- 3844
- Charge Code
- SACCHARLBL
- Description
- The article appears to contain Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient.
- Legal Section
- 403(i), 801(a)(3); Misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | HONGKONG TIANBAO FOOD CO.,LIMITED | Hongkong, HONG KONG | 20 |
| 2 | HONG FUNG TRADING CO. | Sai Ying Pun, HONG KONG | 12 |
| 3 | Kaiping Foods Factory | Guangdong, CHINA | 10 |
| 4 | JIASHENG (ZHANGZHOU)FOOD CO.,LTD. | Fujian Province, CHINA | 8 |
| 5 | XINXING COUNTY HONGBAO FOOD CO., LTD | Jiangmen City, CHINA | 7 |
| 6 | ZHONGSHAN CITY WEST AREA DE FENG COMPANY | Zhongshan, CHINA | 7 |
| 7 | Aleshin E.O | Abakan, RUSSIA | 6 |
| 8 | Hung Yu Agriculture Biotech Enterprise LTD. | Tainan City, TAIWAN | 5 |
| 9 | A S World Trading Co., Ltd. | Samutprakan, THAILAND | 5 |
| 10 | TAIWAN SHUNTAI FOOD CO., LTD. | Ta Tsun, TAIWAN | 5 |
| 11 | Zi Jing Yuk Hin Enterprise Co., Ltd | Heyuan, CHINA | 5 |
| 12 | La Kaffa International Co. | Hsinchu County, TAIWAN | 4 |
| 13 | GETWIN CO. | TAIPEI, TAIWAN | 4 |
| 14 | XINFAZHAN FOODSTUFF CO.,LTD | Longkou, CHINA | 3 |
| 15 | Brasseries du Cameroun | Douala, CAMEROON | 3 |
| 16 | Fujian Lins Heng Fa International Trade Co.,Ltd | Fuzhou, CHINA | 3 |
| 17 | chiu kee trading co | Hong Kong, HONG KONG | 3 |
| 18 | Fujian Fuxing Industrial Imp. & Exp. Corp. | Fuzhou, CHINA | 3 |
| 19 | Ground Bio Tech Co., Ltd. | Changhua City, TAIWAN | 3 |
| 20 | HENGXINWANG FOODSTUFF | Yantai, CHINA | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 3/4/2025 | MANGO (SUBTROPICAL AND TROPICAL FRUIT) 21SHH05 | PA-Siam Intertrade Co. Ltd.THAILAND |
| 3/4/2025 | PLUM (PIT FRUIT) 21GHH14 | PA-Siam Intertrade Co. Ltd.THAILAND |
| 11/19/2024 | BREAD STICKS (FLAVORED OR UNFLAVORED), BAKED 07AFT01 | Aleshin E.ORUSSIA |
| 11/19/2024 | BREAD STICKS (FLAVORED OR UNFLAVORED), BAKED 07AFT01 | Aleshin E.ORUSSIA |
| 3/13/2023 | PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. 03HDT99 | Aleshin E.ORUSSIA |
| 3/13/2023 | PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. 03HDT99 | Aleshin E.ORUSSIA |
| 1/26/2023 | PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. 03HDT99 | Aleshin E.ORUSSIA |
| 1/26/2023 | BREAD STICKS (FLAVORED OR UNFLAVORED), BAKED 07AGT01 | Aleshin E.ORUSSIA |
| 8/9/2022 | OLIVES (PIT FRUIT) 21GGT09 | A S World Trading Co., Ltd.THAILAND |
| 6/30/2022 | GOOSEBERRIES (BERRY) 20AGT08 | A S World Trading Co., Ltd.THAILAND |
| 6/30/2022 | MANGO (SUBTROPICAL AND TROPICAL FRUIT) 21SHI05 | A S World Trading Co., Ltd.THAILAND |
| 7/28/2021 | FRUIT COCTAIL, MIXED FRUIT, JUICES OR CONCENTRATES 21DGT01 | Brasseries du CamerounCAMEROON |
| 3/11/2021 | GRAPEFRUIT, CITRUS FRUIT JUICES OR CONCENTRATES 20KCT02 | Brasseries du CamerounCAMEROON |
| 3/11/2021 | COCKTAIL BASE, COMBINED TRUE FRUIT AND IMITATION FRUIT FLAVORS, LIQUID 30PCT01 | Brasseries du CamerounCAMEROON |
| 5/6/2020 | MANGO (SUBTROPICAL AND TROPICAL FRUIT) 21SGT05 | A S World Trading Co., Ltd.THAILAND |
Frequently Asked Questions
What is FDA violation code 3844?
3844 is an FDA violation code that indicates: "The article appears to contain Saccharin, a non-nutritive sweetener, and its label or labeling fails to list it as an added ingredient.". This violation is based on 403(i), 801(a)(3); Misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3844?
According to FDA Import Refusal data, there have been 180 import refusals issued for violation code 3844, affecting 71 unique firms.
When was the most recent refusal for violation 3844?
The most recent import refusal for violation 3844 was on March 4, 2025.
What products are commonly refused for violation 3844?
Products commonly refused under violation 3844 include: MANGO (SUBTROPICAL AND TROPICAL FRUIT), PLUM (PIT FRUIT), BREAD STICKS (FLAVORED OR UNFLAVORED), BAKED, PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3844?
Violation code 3844 is based on 403(i), 801(a)(3); Misbranding 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.