Violation Code: 256
FDA Violation
Charge Code: INCONSPICU
Violation Details
- Violation Code (ASC ID)
- 256
- Charge Code
- INCONSPICU
- 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
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Laboratorios PiSA, S.A. de C.V (Planta Tlajomulco) | Tlajomulco De Zuniga, MEXICO | 153 |
| 2 | COMERCIALIZADORA PEPSICO | Ciudad De Mexico, MEXICO | 99 |
| 3 | Nutri-Asia, Incorporated dba UFC Philippines | Laguna, PHILIPPINE | 45 |
| 4 | Sociedad Cooperativa Trabajadores De Pascual, S.C.L. | Transito, MEXICO | 43 |
| 5 | Samyang Foods Co Ltd | Seoul, SOUTH KORE | 40 |
| 6 | Comercializadora Pepsico Mexico, | Ciudad De Mexico, MEXICO | 38 |
| 7 | bebidas mundiales,s.a de c.v. | Monterrey, MEXICO | 33 |
| 8 | Oliver Olives, Inc. | Bolton, CANADA | 31 |
| 9 | Mars Pet Care-Lebanon SIte | Lebanon, UNITED STA | 27 |
| 10 | SABRITAS PLANTA CELAYA | Celaya, MEXICO | 26 |
| 11 | A Ricchigia S.R.L | Bronte, ITALY | 25 |
| 12 | Swiss Caps AG | Kirchberg SG, SWITZERLAN | 23 |
| 13 | Gwalia Sweets Pvt Ltd | Ahmedabad, INDIA | 23 |
| 14 | ANDYBELA INC | Ancaster, CANADA | 22 |
| 15 | ER-T GODIS AKTIEBOLAG | Vaxjo, SWEDEN | 22 |
| 16 | Zdenka d.d | Bjelovar, CROATIA | 21 |
| 17 | FOODMASTERGROUP | Jongno, SOUTH KORE | 20 |
| 18 | BRITANNIA INDUSTRIES LIMITED | Kolkata, INDIA | 20 |
| 19 | PRODUCTOS RICOLINO, S.A.P.I. DEC.V. | Ciudad De Mexico, MEXICO | 20 |
| 20 | Kaiser Pharmaceutical Co. | Tainan City, TAIWAN | 19 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/29/2025 | BANANA SAUCE 37JCT13 | |
| 12/29/2025 | BANANA SAUCE 37JCT13 | |
| 12/29/2025 | BANANA SAUCE 37JCE13 | Nutri-AsiaPHILIPPINE |
| 12/29/2025 | SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED 29AGE70 | INDUSTRIAS LACTEAS TONI S.A.ECUADOR |
| 12/19/2025 | RADISH (ROOT & TUBER VEGETABLE) 25JGC07 | |
| 12/19/2025 | RED BEET (ROOT & TUBER VEGETABLE) 25JGC08 | |
| 12/10/2025 | VITAMIN E (TOCOPHEROL) 54ACY16 | ESPECIALIDADES NUTRITONMEXICO |
| 12/10/2025 | VITAMIN E (TOCOPHEROL) 54ACY16 | ESPECIALIDADES NUTRITONMEXICO |
| 12/8/2025 | MIXED/ASSORTED HARD CANDY WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33EYT12 | Indaco S.p.A.ITALY |
| 12/8/2025 | VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. 54YCL99 | REH HERBAL MANUFACTURING CORPPHILIPPINE |
| 12/8/2025 | DIETARY CONVENTIONAL FOODS, N.E.C. 41YYY99 | BIOCOL PHARMA, LDAPORTUGAL |
| 12/4/2025 | CARBONATED SOFT DRINK, N.E.C. 29BCT99 | HELMI FOOD MATERIALSJORDAN |
| 12/4/2025 | CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE) 33GGT05 | HELMI FOOD MATERIALSJORDAN |
| 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 |
Related Violations
Other violations under the same legal section: 403(f), 801(a)(3); MISBRANDING
| Code | Charge Code | Cases |
|---|---|---|
| 324 | NO ENGLISH | 19659 |
Frequently Asked Questions
What is FDA violation code 256?
256 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 256?
According to FDA Import Refusal data, there have been 4714 import refusals issued for violation code 256, affecting 1910 unique firms.
When was the most recent refusal for violation 256?
The most recent import refusal for violation 256 was on December 29, 2025.
What products are commonly refused for violation 256?
Products commonly refused under violation 256 include: BANANA SAUCE, SOFT DRINK, MILK BASED (CHOCOLATE FLAVORED, ETC.), NONCARBONATED, RADISH (ROOT & TUBER VEGETABLE). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 256?
Violation code 256 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.