Violation Code: 324
FDA Violation
Charge Code: NO ENGLISH
Violation Details
- Violation Code (ASC ID)
- 324
- Charge Code
- NO ENGLISH
- 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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
- Legal Section
- 403(f), 801(a)(3); MISBRANDING
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/31/2025 | MILK BREAD/ROLLS/BUNS 03AGT08 | |
| 12/23/2025 | MARSHMALLOW CANDY, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33EYH09 | |
| 12/23/2025 | OTHER FRUIT AND FRUIT PRODUCTS, DRIED AND PASTE, N.E.C. 22HYH99 | |
| 12/23/2025 | ORANGE (CITRUS) 20GYY06 | |
| 12/23/2025 | GUAVA, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT 21VFI04 | |
| 12/23/2025 | FRUIT COCTAIL, MIXED FRUIT, JUICES OR CONCENTRATES 21DFI01 | |
| 12/23/2025 | MANGO, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT 21VFI05 | |
| 12/18/2025 | CORN, BOLTED MEAL OR FLOUR 02BFC01 | |
| 12/17/2025 | ORIENTAL NOODLES (FLAVORED WITH SHRIMP,CHICKEN,BEEF,LOBSTER,CRAB,PLAIN,ETC.) 04CGT08 | |
| 12/17/2025 | MUD FISH 16AGT64 | |
| 12/17/2025 | MUD FISH 16AGT64 | |
| 12/17/2025 | SOFT CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE) 33JGT99 | |
| 12/17/2025 | TOMATO SAUCE (WITH OTHER INGREDIENTS) 37JHT08 | |
| 12/15/2025 | LEAVENING AGENTS (FOOD ADDITIVES FOR HUMAN USE) 45RF99 | SARL TASSALA FOODALGERIA |
| 12/15/2025 | MAYONNAISE 27ACT02 | SARL TASSALA FOODALGERIA |
Related Violations
Other violations under the same legal section: 403(f), 801(a)(3); MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 256 | INCONSPICU | 4714 |
Frequently Asked Questions
What is FDA violation code 324?
324 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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).". This violation is based on 403(f), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 324?
According to FDA Import Refusal data, there have been 19659 import refusals issued for violation code 324, affecting 6390 unique firms.
When was the most recent refusal for violation 324?
The most recent import refusal for violation 324 was on December 31, 2025.
What products are commonly refused for violation 324?
Products commonly refused under violation 324 include: MILK BREAD/ROLLS/BUNS, MARSHMALLOW CANDY, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE), OTHER FRUIT AND FRUIT PRODUCTS, DRIED AND PASTE, N.E.C., ORANGE (CITRUS), GUAVA, JUICE, MILK, CREME, DRINK OR NECTAR, SUB/TROPICAL FRUIT. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 324?
Violation code 324 is based on 403(f), 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.