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 |
|---|---|---|
| 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 |
| 12/16/2025 | ANTI-ECZEMATIC N.E.C. 61SBJ99 | |
| 12/16/2025 | MELON SEEDS (EDIBLE SEED PASTE) 23RGY05 | |
| 12/16/2025 | BETAMETHASONE DIPROPIONATE (GLUCOCORTICOID) 64LMJ06 | |
| 12/16/2025 | LEAF & STEM VEGETABLES, DRIED OR PASTE, N.E.C. 24UGH99 | |
| 12/16/2025 | PUMPKIN SEED (EDIBLE SEED) 23KGH01 | |
| 12/16/2025 | BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) 24AYH99 | |
| 12/16/2025 | MANGO, GROUND, CRACKED SPICE 28BHN64 | |
| 12/16/2025 | BAKED SNACK FOOD, N.E.C. 07AHN99 | |
| 12/16/2025 | BAKED SNACK FOOD, N.E.C. 07AHN99 | |
| 12/16/2025 | CAPSICUMS (CAYENNE CHILI, HOT PEPPERS), GROUND, CRACKED (SPICE) 28BGH08 |
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 8445 import refusals issued for violation code 320, affecting 4026 unique firms.
When was the most recent refusal for violation 320?
The most recent import refusal for violation 320 was on December 17, 2025.
What products are commonly refused for violation 320?
Products commonly refused under violation 320 include: PROTEIN N.E.C., MUD FISH, SYRUP (PHARMACEUTIC NECESSITY - FLAVOR), CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE). 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.