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 |
|---|---|---|
| 1/22/2026 | OTHER SKIN CARE PREPARATIONS, N.E.C. 53LD99 | Cosmax IncSOUTH KORE |
| 1/22/2026 | MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) 54ACY90 | NATURAL MEDY DISTRIBUCIONESCOLOMBIA |
| 1/22/2026 | MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) 54ACY90 | NATURAL MEDY DISTRIBUCIONESCOLOMBIA |
| 1/22/2026 | TEA, BLACK 31KYT01 | |
| 1/21/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | Tower Laboratories Ltd.UNITED STA |
| 1/21/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCR99 | LIOTECNICA TECNOLOGIA EMBRAZIL |
| 1/20/2026 | PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C. 03HGT99 | |
| 1/20/2026 | CORN CHIPS, FRIED 07BGT02 | BARCEL, S.A. DE C.VMEXICO |
| 1/16/2026 | CARDAMON, GROUND, CRACKED (SPICE) 28BGT10 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | MIXED SPICE AND SEAONINGS, WITHOUT SALT, N.E.C. 28ECT99 | MAE KHEM CO LTDTHAILAND |
| 1/16/2026 | CURRY PASTE 37KCN23 | MAE KHEM CO LTDTHAILAND |
| 1/15/2026 | CORN AND PEPPERS, DRIED OR PASTE 25FYY03 | |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 | |
| 1/15/2026 | CAKE WITHOUT CUSTARD OR CREAM FILLING 03RGT01 |
Related Violations
Other violations under the same legal section: 403(f), 801(a)(3); MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 256 | INCONSPICU | 4725 |
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 19742 import refusals issued for violation code 324, affecting 6410 unique firms.
When was the most recent refusal for violation 324?
The most recent import refusal for violation 324 was on January 22, 2026.
What products are commonly refused for violation 324?
Products commonly refused under violation 324 include: OTHER SKIN CARE PREPARATIONS, N.E.C., MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN), TEA, BLACK, 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 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.