Violation Code: 3701
FDA Violation
Charge Code: ALRGN402A4
Violation Details
- Violation Code (ASC ID)
- 3701
- Charge Code
- ALRGN402A4
- Description
- it appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health, specifically because the food appears to contain a major food allergen through insanitary conditions that led to cross-contact.
- Legal Section
- 801(a)(3); 402(a)4; Adulterated
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Da Cheng Vegetarian International Co., Ltd. | , TAIWAN | 7 |
| 2 | Kupiec Sp. z o.o. | Krzymow, POLAND | 5 |
| 3 | Butlers Chocolates, UC | Dublin, IRELAND | 3 |
| 4 | Lotte Wellfood Co., Ltd. (Yangsan Factory) | Yangsan, SOUTH KORE | 3 |
| 5 | ZAVOD STERILIZOVANNOGO MOLOKA MOJAISKIY | Mojaisk, RUSSIA | 3 |
| 6 | TWI Foods Inc. | Etobicoke, CANADA | 2 |
| 7 | Durrset Amigos Ltd. | San Antonio, UNITED STA | 2 |
| 8 | Samyang Foods Co Ltd | Seoul, SOUTH KORE | 2 |
| 9 | Gammoh Trading Partnership | Amman, JORDAN | 2 |
| 10 | Kishwan snacks limited | Nasirabad, BANGLADESH | 2 |
| 11 | Maruto Seika Co., LTD | Fukuyama, JAPAN | 2 |
| 12 | JIANGMEN CHANGHAO IMP.&EXP.CO.,LTD | Jiangmen, CHINA | 1 |
| 13 | GOLDEN SEA COLD STORE AND PROCESSING PLANT | Yangon | 1 |
| 14 | The Morning Star Packing Co. LP | Los Banos, UNITED STA | 1 |
| 15 | ZHONGSHAN HONGWANG FOOD CO LTD | Xhongshan City, CHINA | 1 |
| 16 | Alimentos Maravilla S.A. | Escuintla, GUATEMALA | 1 |
| 17 | PT Bumi Menara Internusa | Surabaya, INDONESIA | 1 |
| 18 | Nestle India Limited - Moga Factory | Atari, INDIA | 1 |
| 19 | Godiva Belgium b.v.b.a. | Koekelberg, BELGIUM | 1 |
| 20 | BANOFUL & CO. | Chittagong, BANGLADESH | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/18/2025 | NOODLES, INSTANT 04CYT07 | |
| 8/26/2025 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CGT01 | |
| 8/26/2025 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CGT01 | |
| 12/26/2024 | SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED 29BHT02 | Alimentos Maravilla S.A.GUATEMALA |
| 5/22/2024 | ZWEIBACK, TOAST 03YGT07 | BANOFUL & CO.BANGLADESH |
| 3/27/2024 | VEGETABLE PROTEIN PRODUCT, MEAT TEXTURED, WITH APPEARANCE OF POULTRY PORTIONS 18BGT03 | |
| 10/12/2023 | CHOCOLATE CANDY BAR, WITHOUT NUTS AND FRUIT 34FFT01 | Butlers Chocolates, UCIRELAND |
| 9/20/2023 | VEGETABLE PROTEIN PRODUCT, MEAT TEXTURED, WITH APPEARANCE OF POULTRY PORTIONS 18BGT03 | |
| 8/14/2023 | VEGETABLE PROTEIN PRODUCT, MEAT TEXTURED, WITH APPEARANCE OF POULTRY PORTIONS 18BGT03 | |
| 8/14/2023 | FISH-TEXTURED VEGETABLE PROTEIN (PRODUCTS HAVING APPEARANCE OF FISH PORTIONS, FILLETS, ETC.) 18DGT01 | |
| 8/14/2023 | VEGETABLE PROTEIN PRODUCT, MEAT TEXTURED, WITH APPEARANCE OF POULTRY PORTIONS 18BGT03 | |
| 8/1/2023 | FISH-TEXTURED VEGETABLE PROTEIN (PRODUCTS HAVING APPEARANCE OF FISH PORTIONS, FILLETS, ETC.) 18DGT01 | |
| 7/6/2023 | PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. 03HGT99 | Kishwan snacks limitedBANGLADESH |
| 7/6/2023 | COOKIE,BISCUIT,WAFER DOUGH, N.E.C. 03MGT99 | Kishwan snacks limitedBANGLADESH |
| 5/11/2023 | VEGETABLE PROTEIN PRODUCT, MEAT TEXTURED, WITH APPEARANCE OF POULTRY PORTIONS 18BGT03 |
Frequently Asked Questions
What is FDA violation code 3701?
3701 is an FDA violation code that indicates: "it appears to be adulterated within the meaning of section 402(a)(4) because it appears that the food was prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health, specifically because the food appears to contain a major food allergen through insanitary conditions that led to cross-contact.". This violation is based on 801(a)(3); 402(a)4; Adulterated of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3701?
According to FDA Import Refusal data, there have been 47 import refusals issued for violation code 3701, affecting 25 unique firms.
When was the most recent refusal for violation 3701?
The most recent import refusal for violation 3701 was on November 18, 2025.
What products are commonly refused for violation 3701?
Products commonly refused under violation 3701 include: NOODLES, INSTANT, CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT), SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED, ZWEIBACK, TOAST. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3701?
Violation code 3701 is based on 801(a)(3); 402(a)4; Adulterated 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.