Violation Code: 3480
FDA Violation
Charge Code: E COLI 157
Violation Details
- Violation Code (ASC ID)
- 3480
- Charge Code
- E COLI 157
- Description
- The article appears to contain E. coli O157:H7 (EHEC), a poisonous and deleterious substance which may render it injurious to health.
- Legal Section
- 402(a)(1), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Lacto Productos Del Sur | Pueblo Palmar Chico, MEXICO | 8 |
| 2 | GEO HEINSEN, S. A. | Imbert, DOMINICAN | 6 |
| 3 | Fromagerie Guilloteau | Belley, FRANCE | 4 |
| 4 | JEAN D'ALOS FROMAGER-AFFINEUR | Bordeaux, FRANCE | 3 |
| 5 | Sapori dell 'Antica Murgia S.a.s. | Santeramo In Colle, ITALY | 2 |
| 6 | Marudhar Impex | Ahmedabad, INDIA | 2 |
| 7 | Caseificio Antichi Sapori | Padula, ITALY | 2 |
| 8 | GFR Pharma Ltd. | Coquitlam, CANADA | 1 |
| 9 | Hubei Qianjiang Huashan Aquatic Food And Product Co., Ltd | Qianjiang, CHINA | 1 |
| 10 | carozzi formaggi. S.R.L. | Pasturo, ITALY | 1 |
| 11 | LA KALITA SC DE RL DE CV | Guaymas, MEXICO | 1 |
| 12 | SESP GROUP | Petakh Tikva, ISRAEL | 1 |
| 13 | TAHSILDAROGLU SUT URUNLERI SANAYI VE TICARET ANONIM SIRKETI | Canakkale, TURKEY | 1 |
| 14 | PT SAHABAT SUKSES KALIMANTAN BARAT | Kuburaya, INDONESIA | 1 |
| 15 | BEST VALYU ORGANIK OOO | Mayma, RUSSIA | 1 |
| 16 | Fcg Trading Philippines Inc | Quezon City, PHILIPPINE | 1 |
| 17 | Laboratorio y Red de Distribucion Vital Health S.A. de C.V. | Hermosillo, MEXICO | 1 |
| 18 | CASEIFICIO PALAZZO SPA | Putignano, ITALY | 1 |
| 19 | Ftrecal | Bulgneville, FRANCE | 1 |
| 20 | Talleys Group | Motueka, NEW ZEALAN | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/3/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCE99 | SESP GROUPISRAEL |
| 9/9/2024 | GARLIC (HERBAL & BOTANICALS, NOT TEAS) 54FCH10 | |
| 5/1/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCI99 | Marudhar ImpexINDIA |
| 4/10/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCI99 | Marudhar ImpexINDIA |
| 12/6/2023 | KRATOM (HERBAL AND BOTANICALS, NOT TEAS II) 54KYT12 | PT SAHABAT SUKSES KALIMANTAN BARATINDONESIA |
| 8/31/2022 | CRAB 16JGC01 | LA KALITA SC DE RL DE CVMEXICO |
| 6/8/2022 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FBR99 | BEST VALYU ORGANIK OOORUSSIA |
| 6/11/2021 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCR99 | GFR Pharma Ltd.CANADA |
| 3/27/2018 | CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) 12AFO19 | GEO HEINSEN, S. A.DOMINICAN |
| 3/27/2018 | CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) 12AFO19 | GEO HEINSEN, S. A.DOMINICAN |
| 3/27/2018 | CHEESE, HARD (CHESIRE,ESRUM,FORTINA,FORTINE,KASSENI,MOZZARELLA,MONTASIO,PECARINO,PORT SALUT, ETC) 12AFO19 | GEO HEINSEN, S. A.DOMINICAN |
| 10/5/2015 | CHEESE, SHEEP, N.E.C. 12CGO16 | |
| 10/5/2015 | CHEESE, SEMISOFT 12AGO52 | |
| 10/5/2015 | CHEESE, SEMISOFT 12AGO52 | |
| 8/16/2013 | CRAYFISH (CRAWFISH), FRESH WATER 16JFN02 |
Related Violations
Other violations under the same legal section: 402(a)(1), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3480?
3480 is an FDA violation code that indicates: "The article appears to contain E. coli O157:H7 (EHEC), a poisonous and deleterious substance which may render it injurious to health.". This violation is based on 402(a)(1), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3480?
According to FDA Import Refusal data, there have been 43 import refusals issued for violation code 3480, affecting 23 unique firms.
When was the most recent refusal for violation 3480?
The most recent import refusal for violation 3480 was on October 3, 2024.
What products are commonly refused for violation 3480?
Products commonly refused under violation 3480 include: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., GARLIC (HERBAL & BOTANICALS, NOT TEAS), KRATOM (HERBAL AND BOTANICALS, NOT TEAS II). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3480?
Violation code 3480 is based on 402(a)(1), 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.