Violation Code: 3841
FDA Violation
Charge Code: AF-NONRSP
Violation Details
- Violation Code (ASC ID)
- 3841
- Charge Code
- AF-NONRSP
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer for this acidified food pursuant to 21 CFR 108.25 (c)(2) appears to be inadequate to protect the public health.
- Legal Section
- 402(a)(4), 801(a)(3);ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Ciemme Alimentari S.r.l. | Barletta, ITALY | 26 |
| 2 | Carl Kuhne KG (GmbH & Co.) | Straelen, GERMANY | 15 |
| 3 | SICHUAN BAIJIA FOOD INDUSTRIAL CO.,LTD | Sichuan, CHINA | 13 |
| 4 | Grandmas Food Products | Muvattupuzha, INDIA | 8 |
| 5 | HUERTA DEHESA ALCORNOCAL SL | SANTA BADAJOZ, SPAIN | 7 |
| 6 | Haldiram Snacks Pvt. Ltd. | Noida, INDIA | 6 |
| 7 | Okechamp B.V. | Velden, NETHERLAND | 4 |
| 8 | Sesajal Sa De Cv | Guadalajara, MEXICO | 3 |
| 9 | Hung Loi Manufacturing and Trading Co. Ltd. | Ho Chi Minh City, VIETNAM | 2 |
| 10 | Good Morning Seoul Corp. | Tongduchon, SOUTH KORE | 2 |
| 11 | Food Processors International Ghana Limited | Tema, GHANA | 2 |
| 12 | Anand Food & Dairy Products | Bedva, INDIA | 2 |
| 13 | PKM FINE FOODS | Cochin, INDIA | 2 |
| 14 | ENVASADORA OAXALISCO S.P.R DE R.I | Arandas, MEXICO | 1 |
| 15 | GOOD FOODS SMA SAPI DE CV | San Miguel De Allende, MEXICO | 1 |
| 16 | Sukhadia Garbaddas Bapuji & Sons | Gopalpura, INDIA | 1 |
| 17 | Beiqi (Fujian)Foods Company Limited | Fuzhou, CHINA | 1 |
| 18 | Marbert S.P.R de R.L. de C.V. | Arandas, MEXICO | 1 |
| 19 | Dulces Regionales Tres Reyes S.A. de C.V. | Zamora, MEXICO | 1 |
| 20 | Rala Food Specialities | Bangalore, INDIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2025 | NOODLES, INSTANT 04CGT07 | |
| 1/22/2025 | MIXED SPICES AND SEASONING WITH SALT, N.E.C. 28JGT99 | |
| 1/22/2025 | SAUCES, N.E.C. 37JGT99 | |
| 1/22/2025 | MIXED SPICES AND SEASONING WITH SALT, N.E.C. 28JGT99 | |
| 1/22/2025 | NOODLES, INSTANT 04CGT07 | |
| 1/22/2025 | NOODLES, INSTANT 04CGT07 | |
| 1/22/2025 | MIXED SPICES AND SEASONING WITH SALT, N.E.C. 28JGT99 | |
| 11/21/2024 | MIXED SPICES AND SEASONING WITH SALT, N.E.C. 28JGT99 | |
| 11/21/2024 | MIXED SPICES AND SEASONING WITH SALT, N.E.C. 28JGT99 | |
| 11/21/2024 | MIXED SPICES AND SEASONING WITH SALT, N.E.C. 28JGT99 | |
| 11/21/2024 | MIXED SPICES AND SEASONING WITH SALT, N.E.C. 28JGT99 | |
| 11/21/2024 | MIXED SPICES AND SEASONING WITH SALT, N.E.C. 28JGT99 | |
| 11/21/2024 | MIXED SPICES AND SEASONING WITH SALT, N.E.C. 28JGT99 | |
| 6/17/2024 | SPICES, GROUND, CRACKED, ETC., N.E.C. 28BGH99 | |
| 2/15/2023 | HOMMUS, HUMMUS (MULTIPLE FOOD SPECIALTIES, SIDE DISHES AND DESSERTS) 37BFT26 |
Frequently Asked Questions
What is FDA violation code 3841?
3841 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to have been prepared or packed under insanitary conditions whereby it may have been rendered injurious to health due to inadequate processing in that the scheduled process filed by the manufacturer for this acidified food pursuant to 21 CFR 108.25 (c)(2) appears to be inadequate to protect the public health.". This violation is based on 402(a)(4), 801(a)(3);ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3841?
According to FDA Import Refusal data, there have been 111 import refusals issued for violation code 3841, affecting 32 unique firms.
When was the most recent refusal for violation 3841?
The most recent import refusal for violation 3841 was on January 22, 2025.
What products are commonly refused for violation 3841?
Products commonly refused under violation 3841 include: NOODLES, INSTANT, MIXED SPICES AND SEASONING WITH SALT, N.E.C., SAUCES, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3841?
Violation code 3841 is based on 402(a)(4), 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.