Violation Code: 308
FDA Violation
Charge Code: MFR INSAN
Violation Details
- Violation Code (ASC ID)
- 308
- Charge Code
- MFR INSAN
- Description
- The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
- Legal Section
- 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Haldiram Snacks Pvt. Ltd. | Noida, INDIA | 283 |
| 2 | Innovative Cuisine Pvt Ltd | VADODARA, INDIA | 244 |
| 3 | QUALITY SPICES & FOOD EXPORTS PVT.LTD. | Ambernath (E), INDIA | 192 |
| 4 | HALDIRAM SNACKS PVT LTD | Noida, INDIA | 165 |
| 5 | Fromagerie Guilloteau | Belley, FRANCE | 160 |
| 6 | Haldiram Snacks Pvt. Ltd. | Noida, INDIA | 150 |
| 7 | Sun Mark Ltd | Greenford, UNITED KIN | 148 |
| 8 | Caseificio Antichi Sapori | Padula, ITALY | 126 |
| 9 | PT. Bahari Makmur Sejati | Serang, INDONESIA | 111 |
| 10 | HALDIRAM SNACKS PVT. LTD. | Noida, INDIA | 77 |
| 11 | CAMPO SANTA MARIA | HERMOSILLO, MEXICO | 76 |
| 12 | Olympic Eel & Salmon Industries SA | Preveza, GREECE | 61 |
| 13 | Haldiram Snacks Pvt. Ltd. | Noida, INDIA | 57 |
| 14 | Nisa International | Grimsby, UNITED KIN | 51 |
| 15 | Fromagerie Rouzaire S.A. | Tournan en Brie, FRANCE | 43 |
| 16 | Agropecuaria Montelibano S.A de C.V. | Namasigue, HONDURAS | 42 |
| 17 | Exportaciones Francisco Perez S.A. | Santiago, DOMINICAN | 41 |
| 18 | GEO HEINSEN, S. A. | Imbert, DOMINICAN | 40 |
| 19 | C.K Frozen Foods Yangon Company Limited | Yangon, MYANMAR | 40 |
| 20 | ADANI FOOD PRODUCTS PVT LTD | Rajkot, INDIA | 39 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/23/2025 | FISH, N.E.C. 16AGD99 | Banyenzako Fish ExpTANZANIA |
| 12/23/2025 | FISH, N.E.C. 16AGD99 | Banyenzako Fish ExpTANZANIA |
| 12/23/2025 | FISH, N.E.C. 16AGT99 | Banyenzako Fish ExpTANZANIA |
| 12/23/2025 | FISH, N.E.C. 16AGT99 | Banyenzako Fish ExpTANZANIA |
| 12/18/2025 | FISH, HOT SMOKED N.E.C. 16IGH99 | ZIDADU TRADINGTANZANIA |
| 12/18/2025 | TILAPIA, HOT SMOKED, FISH 16IGH58 | ZIDADU TRADINGTANZANIA |
| 12/18/2025 | OCEAN PERCH (RED PERCH, PACIFIC PERCH, REDFISH), HOT SMOKED, FISH 16IGH24 | ZIDADU TRADINGTANZANIA |
| 12/18/2025 | HERRING 16AGY21 | ZIDADU TRADINGTANZANIA |
| 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 |
| 12/16/2025 | ANCHOVY 16AGH01 | ZIDADU TRADINGTANZANIA |
| 12/16/2025 | PERCH, FRESH WATER (YELLOW, LAKE) 16AGH26 | ZIDADU TRADINGTANZANIA |
| 12/15/2025 | FISH, N.E.C. 16AGT99 | Banyenzako Fish ExpTANZANIA |
| 12/15/2025 | HERRING 16AET21 | Karagounis Bros. S.A.GREECE |
Related Violations
Other violations under the same legal section: 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING
| Code | Charge Code | Cases |
|---|---|---|
| 3600 | REFUSE EI | 223 |
Frequently Asked Questions
What is FDA violation code 308?
308 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.". This violation is based on 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 308?
According to FDA Import Refusal data, there have been 6154 import refusals issued for violation code 308, affecting 1506 unique firms.
When was the most recent refusal for violation 308?
The most recent import refusal for violation 308 was on December 23, 2025.
What products are commonly refused for violation 308?
Products commonly refused under violation 308 include: FISH, N.E.C., FISH, HOT SMOKED N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 308?
Violation code 308 is based on 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING 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.