Violation Code: 325
FDA Violation
Charge Code: STD NAME
Violation Details
- Violation Code (ASC ID)
- 325
- Charge Code
- STD NAME
- 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(g)(2) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided under Section 401 of the FD&C Act and the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation.
- Legal Section
- 403(g)(2), 801(a)(3); MISBRANDING
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/29/2025 | SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED 29AGE70 | INDUSTRIAS LACTEAS TONI S.A.ECUADOR |
| 12/17/2025 | PROTEIN N.E.C. 54CCU99 | |
| 11/6/2025 | FILLED MILK, CONCENTRATED, EVAPORATED MILK TYPE PRODUCT 14AEE07 | ASERA & ASSOCIATE LTDNIGERIA |
| 10/10/2025 | WINE, SPARKLING (NATURALLY CARBONATED) 32BCP05 | |
| 10/7/2025 | NOODLES, INSTANT 04CGT07 | |
| 9/23/2025 | TODDLER MILK BASED FORMULA/DRINK PRODUCT (12-36 MONTHS), POWDER FORMULA 40PYY07 | Kendal Nutricare Ltd.UNITED KIN |
| 9/18/2025 | ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES 20KGT06 | Alimentos Maravilla S.A.GUATEMALA |
| 9/18/2025 | ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES 20KGT06 | Alimentos Maravilla S.A.GUATEMALA |
| 9/18/2025 | ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES 20KGT06 | Alimentos Maravilla S.A.GUATEMALA |
| 9/18/2025 | ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES 20KGT06 | Alimentos Maravilla S.A.GUATEMALA |
| 9/9/2025 | NOODLES AND NOODLE PRODUCTS, N.E.C. 04CGT99 | Dekko Foods LimitedTHAILAND |
| 9/9/2025 | NOODLES AND NOODLE PRODUCTS, N.E.C. 04CGT99 | COCOLA FOOD PRODUCTS, LTDBANGLADESH |
| 9/4/2025 | BABY AND JUNIOR FOOD N.E.C. 40YYY99 | Kendal Nutricare Ltd.UNITED KIN |
| 8/4/2025 | ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES 20KFT06 | Alimentos Maravilla S.A.GUATEMALA |
| 8/4/2025 | ORANGE, CITRUS FRUIT JUICES OR CONCENTRATES 20KDT06 | Alimentos Maravilla S.A.GUATEMALA |
Related Violations
Other violations under the same legal section: 403(g)(2), 801(a)(3); MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 327 | OPTION ING | 2 |
Frequently Asked Questions
What is FDA violation code 325?
325 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(g)(2) of the FD&C Act in that the article purports to be or is represented as a food for which a definition and standard of identity have been prescribed by regulations as provided under Section 401 of the FD&C Act and the article is not labeled with the name specified in the definition and standard, or the label does not bear the common names of optional ingredients (other than spices, flavoring and coloring) present in such food, insofar as may be required by such regulation.". This violation is based on 403(g)(2), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 325?
According to FDA Import Refusal data, there have been 152 import refusals issued for violation code 325, affecting 65 unique firms.
When was the most recent refusal for violation 325?
The most recent import refusal for violation 325 was on December 29, 2025.
What products are commonly refused for violation 325?
Products commonly refused under violation 325 include: SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED, PROTEIN N.E.C., FILLED MILK, CONCENTRATED, EVAPORATED MILK TYPE PRODUCT, WINE, SPARKLING (NATURALLY CARBONATED), NOODLES, INSTANT. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 325?
Violation code 325 is based on 403(g)(2), 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.