Violation Code: 320
FDA Violation
Charge Code: LACKS FIRM
Violation Details
- Violation Code (ASC ID)
- 320
- Charge Code
- LACKS FIRM
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
- Legal Section
- 403(e)(1), 801(a)(3); MISBRANDING
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | TEA, BLACK 31KYT01 | |
| 1/20/2026 | TEA, BLACK 31KYY01 | Tonic Life S de RLMEXICO |
| 1/15/2026 | TEA, LIQUID 31KHT20 | |
| 1/12/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBR99 | Tonic Life S de RLMEXICO |
| 1/12/2026 | TEA, INSTANT, PLAIN 31KYT30 | Tonic Life S de RLMEXICO |
| 1/12/2026 | TEA, INSTANT, PLAIN 31KYT30 | Tonic Life S de RLMEXICO |
| 1/9/2026 | POTATO CHIPS,FRIED 07BGT06 | |
| 1/9/2026 | SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C. 07YGT99 | |
| 1/7/2026 | CITRUS FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER AND CANDIED, N.E.C. 20JYT99 | PANADERIA LOS TRILLIZOS SA DE CVEL SALVADO |
| 1/2/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBY99 | |
| 12/17/2025 | PROTEIN N.E.C. 54CCU99 | |
| 12/17/2025 | MUD FISH 16AGT64 | |
| 12/17/2025 | MUD FISH 16AGT64 | |
| 12/16/2025 | SYRUP (PHARMACEUTIC NECESSITY - FLAVOR) 55QP13 | |
| 12/16/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SFY99 | cadbury nigeria plcNIGERIA |
Frequently Asked Questions
What is FDA violation code 320?
320 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor. ". This violation is based on 403(e)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 320?
According to FDA Import Refusal data, there have been 8455 import refusals issued for violation code 320, affecting 4030 unique firms.
When was the most recent refusal for violation 320?
The most recent import refusal for violation 320 was on January 22, 2026.
What products are commonly refused for violation 320?
Products commonly refused under violation 320 include: TEA, BLACK, TEA, LIQUID, VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., TEA, INSTANT, PLAIN. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 320?
Violation code 320 is based on 403(e)(1), 801(a)(3); MISBRANDING 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.