Violation Code: 3641
FDA Violation
Charge Code: CHOKE HZRD
Violation Details
- Violation Code (ASC ID)
- 3641
- Charge Code
- CHOKE HZRD
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be unfit for food, because it contains a foreign object which may pose a choking hazard.
- Legal Section
- 402(a)(3), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Jiangsu Winnie Food Co., Ltd. | Nantong, CHINA | 13 |
| 2 | FENG HIS FOOD CORP | DOULIOW CITY, TAIWAN | 10 |
| 3 | Labixiaoxin (Fujian) Foods Industrial Company Limited | Quanzhou, CHINA | 10 |
| 4 | Triko Foods Co., Ltd. Factory 2 | Taichung, TAIWAN | 2 |
| 5 | Nutrialimento Magaza Spr De Rl De C | Aguascalientes, MEXICO | 2 |
| 6 | Tsang Lin Industries Corp. | Taichung, TAIWAN | 2 |
| 7 | HAN SHUO FOOD CO.,LTD | Dacun Township, TAIWAN | 2 |
| 8 | R & T Creation Ltd | Jinhua, CHINA | 1 |
| 9 | Trolli Guangzhou Confectionery Co., Ltd. | Guangzhou, CHINA | 1 |
| 10 | Shan Foods (Private) Limited | Karachi, PAKISTAN | 1 |
| 11 | CUIFONG TEA Marketing Co., LTD | Taichung City, TAIWAN | 1 |
| 12 | SILE S.A de C.V | El Progreso, HONDURAS | 1 |
| 13 | CARGILL INC. | Eddyville, UNITED STA | 1 |
| 14 | Marilena Rodriguez Velasquez | Comayagua, HONDURAS | 1 |
| 15 | Hojiblanca Sociedad Cooperativa Andaluza | Antequera, SPAIN | 1 |
| 16 | I.D.C. Holding | Bratislava - Ruzinov, SLOVAKIA | 1 |
| 17 | Thai Fishsauce Factory (Squid Brand) Co.,Ltd. | Bangkok, THAILAND | 1 |
| 18 | FERRERO POLSKA Sp.z o.o. | Belsk Duzy, POLAND | 1 |
| 19 | Ningbo Gooddays Toy Candy Co | Yinzhou, CHINA | 1 |
| 20 | Productos Shamniryco | Tijuana, MEXICO | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 9/4/2025 | GEL CUPS CANDY 33MGT05 | |
| 9/4/2025 | GEL CUPS CANDY 33MGT05 | |
| 9/4/2025 | GEL CUPS CANDY 33MGT05 | |
| 9/4/2025 | GEL CUPS CANDY 33MGT05 | |
| 9/4/2025 | GEL CUPS CANDY 33MGT05 | |
| 8/20/2025 | GEL CUPS, FRUIT FLAVORED W/FRUIT CANDY 33MGE03 | |
| 8/20/2025 | GEL CUPS, FRUIT FLAVORED W/FRUIT CANDY 33MGE03 | |
| 7/21/2025 | GEL CUPS CANDY 33MGT05 | |
| 7/21/2025 | GEL CUPS CANDY 33MGT05 | |
| 7/21/2025 | GEL CUPS CANDY 33MGT05 | |
| 7/21/2025 | GEL CUPS CANDY 33MGT05 | |
| 7/21/2025 | GEL CUPS CANDY 33MGT05 | |
| 7/21/2025 | GEL CUPS CANDY 33MGT05 | |
| 7/21/2025 | GEL CUPS CANDY 33MGT05 | |
| 7/21/2025 | GEL CUPS CANDY 33MGT05 |
Related Violations
Other violations under the same legal section: 402(a)(3), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3641?
3641 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 be unfit for food, because it contains a foreign object which may pose a choking hazard.". This violation is based on 402(a)(3), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3641?
According to FDA Import Refusal data, there have been 54 import refusals issued for violation code 3641, affecting 20 unique firms.
When was the most recent refusal for violation 3641?
The most recent import refusal for violation 3641 was on September 4, 2025.
What products are commonly refused for violation 3641?
Products commonly refused under violation 3641 include: GEL CUPS CANDY. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3641?
Violation code 3641 is based on 402(a)(3), 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.