Violation Code: 3865
FDA Violation
Charge Code: COLORLABEL
Violation Details
- Violation Code (ASC ID)
- 3865
- Charge Code
- COLORLABEL
- 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.
- Legal Section
- 403(f);801(a)(3);MISBRANDING
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Hemani International | Karachi, PAKISTAN | 14 |
| 2 | CAPITAL NUTRITION INC. | Blainville, CANADA | 10 |
| 3 | Cloetta Holland BV | Oosterhout Nb, NETHERLAND | 8 |
| 4 | MADATHIL EXPORTS | Thrikkariyoor, INDIA | 7 |
| 5 | PURE FOODS COMPANY (PVT) LTD | Lahore, PAKISTAN | 7 |
| 6 | FUJIAN LIXING FOODS CO LTD | Zhangzhou, CHINA | 6 |
| 7 | JORDAN POTATO & CORN CHIPS CO | Zarka Central, JORDAN | 6 |
| 8 | ARGOS FORTUNA SP.Z.O.O | Lowicz, POLAND | 5 |
| 9 | Prodisabor SAS | Barranquilla, COLOMBIA | 5 |
| 10 | Nutri-Asia, Incorporated dba UFC Philippines | Laguna, PHILIPPINE | 5 |
| 11 | COMERCIALIZADORA PEPSICO | Ciudad De Mexico, MEXICO | 5 |
| 12 | ENVASADORA GUGAR, S.A. DE C.V. | Fracc. Tlalixtac De Cabrera, MEXICO | 5 |
| 13 | NORDICBANGERS SWEDISH CANDY | Skovde, SWEDEN | 5 |
| 14 | Alimentos Maravilla S.A. | Escuintla, GUATEMALA | 4 |
| 15 | Gwalia Sweets Pvt Ltd | Ahmedabad, INDIA | 4 |
| 16 | LA COSECHA EXPORT SA | Totonicapan, GUATEMALA | 4 |
| 17 | the new home made kosher bakery | Montreal, CANADA | 4 |
| 18 | Shang Dao Food Co Ltd | Taipei, TAIWAN | 4 |
| 19 | NEGOCIOS Y EXPORTACIONES CHANIN S.A. | Guatemala, GUATEMALA | 4 |
| 20 | Kalvert Foods India Pvt Ltd | Mumbai, INDIA | 4 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 12/4/2025 | TEA, N.E.C. 31KYY99 | ANGELINI PHARMAGERMANY |
| 11/17/2025 | BANANA SAUCE 37JCT13 | |
| 11/17/2025 | BANANA SAUCE 37JCT13 | |
| 11/6/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGH99 | |
| 11/6/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGH99 | |
| 11/6/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGH99 | |
| 11/6/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGH99 | |
| 11/6/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGH99 | |
| 11/6/2025 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGH99 | |
| 11/3/2025 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CYY01 | |
| 10/30/2025 | SAUCES, N.E.C. 37JGT99 | |
| 10/30/2025 | SAUCES, N.E.C. 37JGT99 | |
| 10/24/2025 | SAUCES, N.E.C. 37JGT99 | |
| 10/24/2025 | PISTACHIO, SPREAD 23EYY11 | Mado PasticcerieITALY |
| 10/23/2025 | SWEET GOODS DOUGH OR BATTER WITHOUT CUSTARD OR CREAM FILLING 03TGT99 | PAT SAFCANADA |
Frequently Asked Questions
What is FDA violation code 3865?
3865 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.". 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 3865?
According to FDA Import Refusal data, there have been 273 import refusals issued for violation code 3865, affecting 133 unique firms.
When was the most recent refusal for violation 3865?
The most recent import refusal for violation 3865 was on December 4, 2025.
What products are commonly refused for violation 3865?
Products commonly refused under violation 3865 include: TEA, N.E.C., BANANA SAUCE, CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3865?
Violation code 3865 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.