Violation Code: 3821
FDA Violation
Charge Code: MFR INJ
Violation Details
- Violation Code (ASC ID)
- 3821
- Charge Code
- MFR INJ
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.
- Legal Section
- 402(a)(4),801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | PT. Bahari Makmur Sejati | Serang, INDONESIA | 388 |
| 2 | Haldiram Snacks Pvt. Ltd. | Noida, INDIA | 371 |
| 3 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. | Ambernath (E), INDIA | 272 |
| 4 | Innovative Cuisine Pvt Ltd | VADODARA, INDIA | 241 |
| 5 | Haldiram Snacks Pvt. Ltd. | Noida, INDIA | 132 |
| 6 | HALDIRAM SNACKS PVT LTD | Noida, INDIA | 118 |
| 7 | HALDIRAM SNACKS PVT. LTD. | Noida, INDIA | 90 |
| 8 | Haldiram Snacks Pvt. Ltd. | Noida, INDIA | 80 |
| 9 | Olympic Eel & Salmon Industries SA | Preveza, GREECE | 48 |
| 10 | ADANI FOOD PRODUCTS PVT LTD | Rajkot, INDIA | 39 |
| 11 | PT Natural Java Spice | Surabaya, INDONESIA | 29 |
| 12 | BORA AGRO FOODS | Pune, INDIA | 25 |
| 13 | Haldiram Manufacturing Co. Pvt. Ltd. | Gurgaon, INDIA | 20 |
| 14 | Al Kanater S.A.L. | Beirut, LEBANON | 17 |
| 15 | El Rashidi El Mizan Confectionery | 6th Of October City, EGYPT | 14 |
| 16 | Haldiram Foods International Pvt. Ltd | Nagpur, INDIA | 11 |
| 17 | Kasih Factories Group for Foodstuff | Arizona Zarqa, JORDAN | 10 |
| 18 | Green Co., Ltd. | Cheongdo, SOUTH KORE | 10 |
| 19 | Wan Shen Biotechnology Farm (Huang Sheng Syong) | Nantou City, TAIWAN | 9 |
| 20 | JAY CHIKKI & SNACKS PVT LTD | Mumbai, INDIA | 8 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/17/2025 | SHRIMP & PRAWNS, BREADED 16KYY05 | PT. Bahari Makmur SejatiINDONESIA |
| 12/17/2025 | SHRIMP & PRAWNS, BREADED 16KYD05 | PT. Bahari Makmur SejatiINDONESIA |
| 12/17/2025 | SHRIMP & PRAWNS, BREADED 16KYY05 | PT. Bahari Makmur SejatiINDONESIA |
| 12/11/2025 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 12/11/2025 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 12/11/2025 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 12/11/2025 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 12/11/2025 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 12/11/2025 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 12/11/2025 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 12/11/2025 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 12/11/2025 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 12/11/2025 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 12/11/2025 | SHRIMP & PRAWNS, BREADED 16KYD05 | PT. Bahari Makmur SejatiINDONESIA |
| 12/11/2025 | SHRIMP & PRAWNS, BREADED 16KYD05 | PT. Bahari Makmur SejatiINDONESIA |
Frequently Asked Questions
What is FDA violation code 3821?
3821 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to 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 3821?
According to FDA Import Refusal data, there have been 2124 import refusals issued for violation code 3821, affecting 99 unique firms.
When was the most recent refusal for violation 3821?
The most recent import refusal for violation 3821 was on December 17, 2025.
What products are commonly refused for violation 3821?
Products commonly refused under violation 3821 include: SHRIMP & PRAWNS, BREADED, SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3821?
Violation code 3821 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.