Violation Code: 2040
FDA Violation
Charge Code: SULFITELBL
Violation Details
- Violation Code (ASC ID)
- 2040
- Charge Code
- SULFITELBL
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.
- Legal Section
- 403(a)(1), 801(a)(3) ;MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | NEVA CONFECTIONERY | Sankt-Peterburg, RUSSIA | 37 |
| 2 | Mega Marine Pride | Pasuruan, INDONESIA | 37 |
| 3 | Baltimore Dominicana S.A. | Santiago, DOMINICAN | 34 |
| 4 | Kimlan Foods Co., Ltd. | Taoyuan City, TAIWAN | 31 |
| 5 | KITCHEN XPRESS OVERSEAS LTD | Gujarat, INDIA | 27 |
| 6 | Green Giant Co., Ltd. | Banpong, THAILAND | 23 |
| 7 | SAD, Division of Pioneer Foods LTD | Wellington, SOUTH AFRI | 18 |
| 8 | PALETERIA TUTI'S | Encarnacion De Diaz, MEXICO | 15 |
| 9 | Escaba Food Products, Incorporated | San Pablo City, PHILIPPINE | 15 |
| 10 | NL Food B.V. | 's-Gravendeel, NETHERLAND | 13 |
| 11 | Zhejiang Suntech Import & Export Co.,Ltd | Hoangzhou, CHINA | 13 |
| 12 | SHANGHAI SINCE FOREVER NORI CO. LTD. | Shanghai, CHINA | 11 |
| 13 | Malayalam Exports | Ernakulam, INDIA | 10 |
| 14 | Aling Conching Native Products | Pampanga, PHILIPPINE | 9 |
| 15 | MY THANH CO.,LTD. | Ho Chih Minh City, VIETNAM | 9 |
| 16 | PANG LI TRADING CO | Sheung Wan, HONG KONG | 8 |
| 17 | Ramdev Food Products Pvt Ltd | Changodar, INDIA | 8 |
| 18 | HAJI BASHIR AHMAD LTD | Kabul, AFGHANISTA | 8 |
| 19 | Taishan City Daxin Food Co., Ltd. | Taishan City, CHINA | 8 |
| 20 | BRITANNIA INDUSTRIES LIMITED | Kolkata, INDIA | 7 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/6/2025 | OTHER FRUITS, MIXED, DRIED OR PASTE 21BYH09 | Gui Nan Hong Company LimitedHONG KONG |
| 11/6/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBT99 | Gui Nan Hong Company LimitedHONG KONG |
| 10/23/2025 | SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS 16XGN21 | Mega Marine PrideINDONESIA |
| 10/14/2025 | MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C. 28EGT99 | Stc India Pvt. Ltd.INDIA |
| 10/9/2025 | PLUM, DRIED OR PASTE 21HGT14 | Khalid Walid Ghalibi LtdAFGHANISTA |
| 9/23/2025 | SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS 16XGT21 | Mega Marine PrideINDONESIA |
| 9/18/2025 | BANANA SNACKS, FRUIT SNACK FOODS, FRIED/OIL COOKED 07HGT01 | Malayalam ExportsINDIA |
| 9/17/2025 | APRICOT, DRIED OR PASTE 21HYY01 | Ashrafi Food IndustriesPAKISTAN |
| 9/15/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBT99 | Gui Nan Hong Company LimitedHONG KONG |
| 9/5/2025 | APRICOT, DRIED OR PASTE 21HGH01 | |
| 8/26/2025 | RAISINS (DRIED GRAPES) (BERRY) 20AGT10 | |
| 8/21/2025 | SHRIMP & PRAWNS, CAKES, BALLS, ETC. 16LYT05 | Seagarden ASNORWAY |
| 8/19/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGT99 | |
| 8/19/2025 | APRICOT, DRIED OR PASTE 21HYN01 | MUSLIM CHAKARI TRADING COMPANYAFGHANISTA |
| 7/23/2025 | SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS 16XGN21 | Mega Marine PrideINDONESIA |
Frequently Asked Questions
What is FDA violation code 2040?
2040 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 misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.". This violation is based on 403(a)(1), 801(a)(3) ;MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2040?
According to FDA Import Refusal data, there have been 892 import refusals issued for violation code 2040, affecting 331 unique firms.
When was the most recent refusal for violation 2040?
The most recent import refusal for violation 2040 was on November 6, 2025.
What products are commonly refused for violation 2040?
Products commonly refused under violation 2040 include: OTHER FRUITS, MIXED, DRIED OR PASTE, HERBALS & BOTANICALS (NOT TEAS), N.E.C., SHRIMP AND PRAWNS, AQUACULTURE HARVESTED FISHERY/SEAFOOD PRODUCTS, MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C., PLUM, DRIED OR PASTE. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2040?
Violation code 2040 is based on 403(a)(1), 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.