Violation Code: 306
FDA Violation
Charge Code: INSANITARY
Violation Details
- Violation Code (ASC ID)
- 306
- Charge Code
- INSANITARY
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or 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 | Fromagerie Guilloteau | Belley, FRANCE | 160 |
| 2 | Voortman Cookies Limited | Burlington, CANADA | 157 |
| 3 | Caseificio Antichi Sapori | Padula, ITALY | 127 |
| 4 | Kader Exports Private Limited | Bhimavaram, INDIA | 79 |
| 5 | CAMPO SANTA MARIA | HERMOSILLO, MEXICO | 76 |
| 6 | Perrin-Vermot SA | Cleron, FRANCE | 53 |
| 7 | Oliver Olives, Inc. | Bolton, CANADA | 49 |
| 8 | GEO HEINSEN, S. A. | Imbert, DOMINICAN | 47 |
| 9 | Agropecuaria Montelibano S.A de C.V. | Namasigue, HONDURAS | 40 |
| 10 | chilchota alimentos s.a. de c.v. | Gomez Palacio, MEXICO | 39 |
| 11 | Cora Formiaggi di Gianni Cora s.a.s | Monesiglio, ITALY | 37 |
| 12 | Sham Gardens Food Industries | Damascus, SYRIA | 35 |
| 13 | BAIG EXPORT INC | Karachi, PAKISTAN | 33 |
| 14 | SOCIETE AFFINAGE ET CONDITIONNEMENT | Roquefort Sur Soulzon, FRANCE | 28 |
| 15 | Sustainable Seafood Co., Ltd. | Cam Lam, VIETNAM | 27 |
| 16 | Cooperative Laiterie La Dent Du Cha | Yenne, FRANCE | 26 |
| 17 | Timothys World Coffee | Toronto, CANADA | 26 |
| 18 | Sucesores Luis Torres y Cia. | Tecoluca, EL SALVADO | 25 |
| 19 | M-C Dairy Limited | Etobicoke, CANADA | 24 |
| 20 | NAMPRIK MAE-ANONG CO., LTD. | Bangkok, THAILAND | 24 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/12/2025 | ANCHOVY 16AGY01 | HEPUNG SUSAN CO.,SOUTH KORE |
| 11/25/2025 | BREAD/ROLLS/BUNS, N.E.C. 03AGT99 | MARIBEL TEMUGUATEMALA |
| 11/21/2025 | MILKFISH 16AGD53 | |
| 11/21/2025 | MILKFISH, HOT SMOKED, FISH 16IGH53 | |
| 11/21/2025 | MILKFISH 16AGD53 | |
| 11/21/2025 | MILKFISH 16AGD53 | |
| 11/21/2025 | MILKFISH 16AGD53 | |
| 11/17/2025 | GARLIC BULB (ROOT & TUBER VEGETABLE) 25JFC21 | |
| 11/4/2025 | OYSTERS 16EGD03 | JBRSOUTH KORE |
| 11/4/2025 | OYSTERS 16EGD03 | JBRSOUTH KORE |
| 10/28/2025 | BONITO 16AVD07 | |
| 10/21/2025 | CANTALOUPE (VINE FRUIT) 22AGK01 | JA PACIFIC SALES CO INCUNITED STA |
| 10/21/2025 | CANTALOUPE (VINE FRUIT) 22AGK01 | JA PACIFIC SALES CO INCUNITED STA |
| 10/20/2025 | CANTALOUPE (VINE FRUIT) 22AGK01 | JA PACIFIC SALES CO INCUNITED STA |
| 10/20/2025 | CANTALOUPE (VINE FRUIT) 22AGK01 | JA PACIFIC SALES CO INCUNITED STA |
Related Violations
Other violations under the same legal section: 402(a)(4), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 306?
306 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 have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or 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 306?
According to FDA Import Refusal data, there have been 4036 import refusals issued for violation code 306, affecting 1356 unique firms.
When was the most recent refusal for violation 306?
The most recent import refusal for violation 306 was on December 12, 2025.
What products are commonly refused for violation 306?
Products commonly refused under violation 306 include: ANCHOVY, BREAD/ROLLS/BUNS, N.E.C., MILKFISH, MILKFISH, HOT SMOKED, FISH. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 306?
Violation code 306 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.