Violation Code: 260
FDA Violation
Charge Code: FALSE
Violation Details
- Violation Code (ASC ID)
- 260
- Charge Code
- FALSE
- 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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
- Legal Section
- 403(a)(1), 801(a)(3); MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | COMERCIALIZADORA PEPSICO | Ciudad De Mexico, MEXICO | 167 |
| 2 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga, MEXICO | 161 |
| 3 | Fresh Hemp Foods, Ltd. | Winnipeg, CANADA | 77 |
| 4 | Nestle India Limited | Bicholim, INDIA | 73 |
| 5 | Nutri-Asia, Incorporated dba UFC Philippines | Laguna, PHILIPPINE | 70 |
| 6 | BIOCOL PHARMA, LDA | Alcabideche, PORTUGAL | 69 |
| 7 | Samyang Foods Co Ltd | Seoul, SOUTH KORE | 57 |
| 8 | Philicon-97 S.A. | Plovdiv, BULGARIA | 46 |
| 9 | Sudip And Company | Mumbai, INDIA | 44 |
| 10 | Petfoodnz International | Gisborne, NEW ZEALAN | 42 |
| 11 | MOLINO E PASTIFICIO DE CECCO SPA PESCARA | Ortona, ITALY | 36 |
| 12 | BARCEL, S.A. DE C.V | Pueblo Infonavit Lerma, MEXICO | 33 |
| 13 | Multifoods S.A.C. | Lima, PERU | 33 |
| 14 | ITN Food | Toronto, CANADA | 30 |
| 15 | OKF Corporation | Andong-si, SOUTH KORE | 29 |
| 16 | Hipp GmbH & CO Vertrieb KG | Pfaffenhofen A.d.ilm, GERMANY | 28 |
| 17 | Comercializadora Pepsico Mexico, | Ciudad De Mexico, MEXICO | 27 |
| 18 | Sociedad Cooperativa Trabajadores De Pascual, S.C.L. | Transito, MEXICO | 27 |
| 19 | Maabarot Products Ltd. | Ma'Abarot, ISRAEL | 24 |
| 20 | SABRITAS, S.de R.L. de C.V. | Ciudad De Mexico, MEXICO | 22 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | BIOCOL PHARMA, LDAPORTUGAL |
| 1/22/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | BIOCOL PHARMA, LDAPORTUGAL |
| 1/21/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | LABIALFARMA SAPORTUGAL |
| 1/21/2026 | HERBALS & BOTANICALS (NOT TEAS), N.E.C. 54FCY99 | LABIALFARMA SAPORTUGAL |
| 1/21/2026 | FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS 41BYY99 | BIOCOL LABSPORTUGAL |
| 1/21/2026 | CHOLINE (MINERAL) 54BCY03 | BIOCOL PHARMA, LDAPORTUGAL |
| 1/21/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | BIOCOL PHARMA, LDAPORTUGAL |
| 1/21/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | BIOCOL PHARMA, LDAPORTUGAL |
| 1/21/2026 | VITAMIN, N.E.C. 54ACY99 | BIOCOL PHARMA, LDAPORTUGAL |
| 1/21/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | BIOCOL PHARMA, LDAPORTUGAL |
| 1/21/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YBE99 | BIOCOL PHARMA, LDAPORTUGAL |
| 1/21/2026 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | BIOCOL PHARMA, LDAPORTUGAL |
| 1/15/2026 | OTHER BAKERY PRODUCTS, N.E.C. 03YGT99 | Unipex Trade CorporationBANGLADESH |
| 1/15/2026 | RAISINS (DRIED GRAPES) (BERRY) 20AAH10 | IRFAN AHMAD LTDAFGHANISTA |
| 1/14/2026 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCY99 | FUTURE NOW 360ESTONIA |
Frequently Asked Questions
What is FDA violation code 260?
260 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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.". This violation is based on 403(a)(1), 801(a)(3); MISBRANDING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 260?
According to FDA Import Refusal data, there have been 5163 import refusals issued for violation code 260, affecting 2022 unique firms.
When was the most recent refusal for violation 260?
The most recent import refusal for violation 260 was on January 22, 2026.
What products are commonly refused for violation 260?
Products commonly refused under violation 260 include: VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C., HERBALS & BOTANICALS (NOT TEAS), N.E.C., FOODS WITH SUPPLEMENTAL NUTRIENTS ADDED, WITH OR WITHOUT ARTIFICAL SWEETNERS. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 260?
Violation code 260 is based on 403(a)(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.