Violation Code: 488
FDA Violation
Charge Code: HEALTH C
Violation Details
- Violation Code (ASC ID)
- 488
- Charge Code
- HEALTH C
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
- Legal Section
- 801(a)(3); 403(r)(1)(A)/(B) misbranding
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Hemani International | Karachi, PAKISTAN | 105 |
| 2 | Fresh Hemp Foods, Ltd. | Winnipeg, CANADA | 76 |
| 3 | ONE Group | Ashmore, AUSTRALIA | 60 |
| 4 | Larrearx | Vancouver, CANADA | 26 |
| 5 | MERIDIAN EXPRESS LIMITED | Accra, GHANA | 26 |
| 6 | OMEGA NUTRITION | Hidalgo Del Parral, MEXICO | 23 |
| 7 | Shubh Psyllium Industries | Brahamanwada, INDIA | 22 |
| 8 | Laboratorios Julguer | Guayaquil, ECUADOR | 20 |
| 9 | Gladys Saldana Mieres | Santiago, CHILE | 18 |
| 10 | Nestle India Ltd | New Delhi, INDIA | 17 |
| 11 | Indian Remedies | Ahmedabadahmedabad, INDIA | 16 |
| 12 | Galafarm | Kyiv, UKRAINE | 15 |
| 13 | Health Supplements | Tourlaville, FRANCE | 15 |
| 14 | C & C PERU S.A.C. | Sachaca, PERU | 14 |
| 15 | NATURAL CORPORATION DO BRAZIL INDUSTRIA E COMERCIO LTDA | Sao Paulo, BRAZIL | 13 |
| 16 | Denk Pharma GmbH & Co. KG | Munich, GERMANY | 13 |
| 17 | Eu Supplements | Bunnik, NETHERLAND | 13 |
| 18 | Webber | Burnaby, CANADA | 12 |
| 19 | Pukka Herbs | Bristolbristol, UNITED KIN | 12 |
| 20 | Interactive Nutrition | Ottawa, CANADA | 12 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/13/2025 | MIXED CEREAL, QUICK OR INSTANT COOKING 05BGT05 | NESTLE NIGERIANIGERIA |
| 12/3/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | |
| 12/3/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | Sheth BrothersINDIA |
| 12/3/2025 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | Sheth BrothersINDIA |
| 10/31/2025 | OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA 40PYY99 | HOLLE FOODSWITZERLAN |
| 9/18/2025 | VITAMIN, N.E.C. 54ABY99 | Ancient GreenfieldsINDIA |
| 9/17/2025 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYT99 | PIO PHARM CO., LTD.SOUTH KORE |
| 8/29/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | PROZIS.comPORTUGAL |
| 8/29/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCE99 | PROZIS.comPORTUGAL |
| 8/29/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | PROZIS.comPORTUGAL |
| 8/29/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCE99 | PROZIS.comPORTUGAL |
| 8/29/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | PROZIS.comPORTUGAL |
| 8/29/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCU99 | LABORATORIOS ENERXIS S.A.SCOLOMBIA |
| 8/27/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | EMPWR CANADACANADA |
| 8/18/2025 | WHEAT CEREAL (BABY) 40BYY06 | Nestle - Halifax plantUNITED KIN |
Frequently Asked Questions
What is FDA violation code 488?
488 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.". This violation is based on 801(a)(3); 403(r)(1)(A)/(B) misbranding of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 488?
According to FDA Import Refusal data, there have been 2319 import refusals issued for violation code 488, affecting 932 unique firms.
When was the most recent refusal for violation 488?
The most recent import refusal for violation 488 was on December 13, 2025.
What products are commonly refused for violation 488?
Products commonly refused under violation 488 include: MIXED CEREAL, QUICK OR INSTANT COOKING, HERBALS & BOTANICALS (NOT TEAS), N.E.C., OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 488?
Violation code 488 is based on 801(a)(3); 403(r)(1)(A)/(B) 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.