Violation Code: 309
FDA Violation
Charge Code: FORBIDDEN
Violation Details
- Violation Code (ASC ID)
- 309
- Charge Code
- FORBIDDEN
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported.
- Legal Section
- 801(a)(2); FORBIDDEN OR RESTRICTED IN SALE
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Herbaland Naturals Inc | Richmond, CANADA | 53 |
| 2 | HERBALAND NATURALS INC | Richmond, CANADA | 24 |
| 3 | L'EPICIER Butsuryu | Kawachi-Gun, JAPAN | 10 |
| 4 | His Church Charity | Market Rasen, UNITED KIN | 5 |
| 5 | Premier Exports London Ltd | Watford, UNITED KIN | 4 |
| 6 | Horyo Corporation | Narita, JAPAN | 4 |
| 7 | THE HIMALAYA WELLNESS LTD | Industrial Area Banga, INDIA | 3 |
| 8 | International Dairy Direct | Sunderland, CANADA | 3 |
| 9 | Friesland Campina | Amersfoort, NETHERLAND | 3 |
| 10 | HERBALAND NATURALS INC | Richmond, CANADA | 3 |
| 11 | RECON OIL INDUSTRIES LIMITED | Mumbai, INDIA | 2 |
| 12 | Nestle India | New Delhi, INDIA | 2 |
| 13 | Atisan Phumchucsh | Muang Phetchaburi, THAILAND | 2 |
| 14 | OTAKE CO.,LTD. | Shizuoka, JAPAN | 2 |
| 15 | Guangdong Yifang Pharmaceutical Co., Ltd | Guangdong, CHINA | 2 |
| 16 | Cadbury Trebor Bassett | Birmingham, UNITED KIN | 2 |
| 17 | Hindustan Lever Limited | Mumbai, INDIA | 2 |
| 18 | Himalaya Wellness Company | Bengaluru, INDIA | 2 |
| 19 | Nagano Tomato Co., Ltd. | Matsumoto, JAPAN | 2 |
| 20 | Healthy Herb Tradi | Georgetown, MALAYSIA | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 4/2/2025 | NOODLES AND NOODLE PRODUCTS, N.E.C. 04CGT99 | Nestle IndiaINDIA |
| 4/2/2025 | NOODLES AND NOODLE PRODUCTS, N.E.C. 04CGT99 | Nestle IndiaINDIA |
| 6/13/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCU99 | Herbaland Naturals IncCANADA |
| 6/13/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCU99 | Herbaland Naturals IncCANADA |
| 6/13/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCU99 | Herbaland Naturals IncCANADA |
| 6/13/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCU99 | Herbaland Naturals IncCANADA |
| 6/13/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCU99 | Herbaland Naturals IncCANADA |
| 6/13/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCU99 | Herbaland Naturals IncCANADA |
| 6/13/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCU99 | Herbaland Naturals IncCANADA |
| 6/13/2024 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCU99 | Herbaland Naturals IncCANADA |
| 6/11/2024 | VITAMIN, N.E.C. 54ACU99 | Herbaland Naturals IncCANADA |
| 6/11/2024 | VITAMIN, N.E.C. 54ACU99 | Herbaland Naturals IncCANADA |
| 6/11/2024 | VITAMIN, N.E.C. 54ACU99 | Herbaland Naturals IncCANADA |
| 6/11/2024 | VITAMIN, N.E.C. 54ACU99 | Herbaland Naturals IncCANADA |
| 6/11/2024 | VITAMIN, N.E.C. 54ACU99 | Herbaland Naturals IncCANADA |
Frequently Asked Questions
What is FDA violation code 309?
309 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported.". This violation is based on 801(a)(2); FORBIDDEN OR RESTRICTED IN SALE of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 309?
According to FDA Import Refusal data, there have been 162 import refusals issued for violation code 309, affecting 51 unique firms.
When was the most recent refusal for violation 309?
The most recent import refusal for violation 309 was on April 2, 2025.
What products are commonly refused for violation 309?
Products commonly refused under violation 309 include: NOODLES AND NOODLE PRODUCTS, N.E.C., VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 309?
Violation code 309 is based on 801(a)(2); FORBIDDEN OR RESTRICTED IN SALE 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.