Violation Code: 487
FDA Violation
Charge Code: SACCHARIN
Violation Details
- Violation Code (ASC ID)
- 487
- Charge Code
- SACCHARIN
- Description
- The article contains Saccharin, a non-nutritive sweetner, and its label or labeling fails to bear the required warning statement.
- Legal Section
- 403(o); 801(a)(3) Misbranded
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | V.K.ENTERPRISE | Mumbai, INDIA | 12 |
| 2 | Britvic Soft Drinks | W Midlands, UNITED KIN | 11 |
| 3 | Britvic Soft Drinks Limited | Solihull, UNITED KIN | 9 |
| 4 | Mei Yuan Preserved Co.,LTD | Yi Lan City, TAIWAN | 8 |
| 5 | Bmv Distributiors | London, UNITED KIN | 7 |
| 6 | Sunan Candy Factory Co., Ltd | Shantou, CHINA | 6 |
| 7 | Robinsons Soft Drinks Ltd. | Chelmsford, UNITED KIN | 4 |
| 8 | Britvic Soft Drinks | W Midlands, UNITED KIN | 4 |
| 9 | Coca-Cola Enterprises Ltd. | Uxbridge, UNITED KIN | 3 |
| 10 | Chin Chi Shun Industrial Co., Ltd. | Kaohsiung Hsien, TAIWAN | 3 |
| 11 | SHENZHEN AOXINTAI IMP. & EXP. TR | Shenzhen, CHINA | 3 |
| 12 | Zhongshan Kunbo Foodstuff Import & Export Corp. Ltd. | Zhongshan, CHINA | 3 |
| 13 | Come In Trading | Hong Kong, HONG KONG | 3 |
| 14 | Daxin Huafeng Food Co. Ltd. | Taishan, CHINA | 2 |
| 15 | Wing Tai Trading Company | Sai Kung, HONG KONG | 2 |
| 16 | Global Goods & Services Holding Ltd. | Shanghai, CHINA | 2 |
| 17 | Hong Xing Textile Prodcuts Co Ltd | Zhangpuzhangpu, CHINA | 2 |
| 18 | A.G. Barr | Glasgow G31, UNITED KIN | 2 |
| 19 | Jiangmen Pioneer Import & Export Co.,Ltd. | Jiangmen, CHINA | 2 |
| 20 | Sunming & Company | Sai Ying Pun, HONG KONG | 2 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/9/2011 | PLUM (PIT FRUIT) 21GGT14 | |
| 1/5/2011 | ORAL REHYDRATION PRODUCTS 41GHT03 | Scandipharm IncUNITED STA |
| 7/1/2010 | PLUM, DRIED OR PASTE 21HGT14 | |
| 6/14/2010 | PRUNES (DRIED PLUMS), DRIED OR PASTE 21HGT15 | Come In TradingHONG KONG |
| 6/4/2010 | DATES, DRIED OR PASTE 21HGT05 | |
| 4/20/2010 | PLUM, DRIED OR PASTE 21HGT14 | |
| 4/14/2010 | BERRIES, MIXED, DRIED OR PASTE 21BAB03 | |
| 3/24/2010 | PRUNES (DRIED PLUMS), JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED 21JMT15 | |
| 2/25/2010 | PRUNES (DRIED PLUMS), DRIED OR PASTE 21HGT15 | Come In TradingHONG KONG |
| 2/1/2010 | PLUM, DRIED OR PASTE 21HGT14 | |
| 1/21/2010 | APRICOT, DRIED OR PASTE 21HGT01 | Ever Rich Trading Hong Kong LtdHONG KONG |
| 11/10/2009 | LEAF & STEM VEGETABLES, WITH SAUCE, N.E.C. 24VEE99 | NisaWay / Bibby DistributionUNITED KIN |
| 10/27/2009 | MANGO, DRIED OR PASTE 21TGH05 | Tang Hoi Moom Kee Co., Ltd.HONG KONG |
| 10/26/2009 | BERRIES, DRIED OR PASTE, N.E.C. 20BGT99 | |
| 10/5/2009 | CORE FRUIT, DRIED OR PASTE, N.E.C. 20QGH99 |
Frequently Asked Questions
What is FDA violation code 487?
487 is an FDA violation code that indicates: "The article contains Saccharin, a non-nutritive sweetner, and its label or labeling fails to bear the required warning statement.". This violation is based on 403(o); 801(a)(3) Misbranded of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 487?
According to FDA Import Refusal data, there have been 142 import refusals issued for violation code 487, affecting 70 unique firms.
When was the most recent refusal for violation 487?
The most recent import refusal for violation 487 was on November 9, 2011.
What products are commonly refused for violation 487?
Products commonly refused under violation 487 include: PLUM (PIT FRUIT), ORAL REHYDRATION PRODUCTS, PLUM, DRIED OR PASTE, PRUNES (DRIED PLUMS), DRIED OR PASTE, DATES, DRIED OR PASTE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 487?
Violation code 487 is based on 403(o); 801(a)(3) Misbranded 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.