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 | IRC WILLIAM DI CARLO SRL | Sulmona, ITALY | 10 |
| 3 | CAPITAL NUTRITION INC. | Blainville, CANADA | 10 |
| 4 | Cloetta Holland BV | Oosterhout Nb, NETHERLAND | 8 |
| 5 | MADATHIL EXPORTS | Thrikkariyoor, INDIA | 7 |
| 6 | PURE FOODS COMPANY (PVT) LTD | Lahore, PAKISTAN | 7 |
| 7 | JORDAN POTATO & CORN CHIPS CO | Zarka Central, JORDAN | 6 |
| 8 | FUJIAN LIXING FOODS CO LTD | Zhangzhou, CHINA | 6 |
| 9 | ARGOS FORTUNA SP.Z.O.O | Lowicz, POLAND | 5 |
| 10 | Prodisabor SAS | Barranquilla, COLOMBIA | 5 |
| 11 | Nutri-Asia, Incorporated dba UFC Philippines | Laguna, PHILIPPINE | 5 |
| 12 | COMERCIALIZADORA PEPSICO | Ciudad De Mexico, MEXICO | 5 |
| 13 | ENVASADORA GUGAR, S.A. DE C.V. | Fracc. Tlalixtac De Cabrera, MEXICO | 5 |
| 14 | NORDICBANGERS SWEDISH CANDY | Skovde, SWEDEN | 5 |
| 15 | Alimentos Maravilla S.A. | Escuintla, GUATEMALA | 4 |
| 16 | Gwalia Sweets Pvt Ltd | Ahmedabad, INDIA | 4 |
| 17 | AIMAN FOOD AND BEVERAGES CO | Karachi, PAKISTAN | 4 |
| 18 | Kalvert Foods India Pvt Ltd | Mumbai, INDIA | 4 |
| 19 | the new home made kosher bakery | Montreal, CANADA | 4 |
| 20 | Shang Dao Food Co Ltd | Taipei, TAIWAN | 4 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/20/2026 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGT99 | Bubs GodisSWEDEN |
| 1/20/2026 | FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) 33EGT06 | |
| 1/20/2026 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CFY01 | |
| 1/20/2026 | CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT) 34CFY01 | |
| 1/20/2026 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGT99 | Bubs GodisSWEDEN |
| 1/20/2026 | CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) 33SGT99 | Bubs GodisSWEDEN |
| 1/6/2026 | CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT) 34CFB99 | |
| 1/6/2026 | CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT) 34CFB99 | |
| 1/6/2026 | CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT) 34CFB99 | |
| 1/6/2026 | CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT) 34CFB99 | |
| 1/6/2026 | CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT) 34CFB99 | |
| 1/6/2026 | CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT) 34CFB99 | |
| 1/6/2026 | CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT) 34CFB99 | |
| 1/6/2026 | CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT) 34CFB99 | |
| 1/6/2026 | CHOCOLATE AND CHOCOLATE COVERED CANDY, WITH NUTS OR NUT PRODUCTS, N.E.C. (NOT COCONUT) 34CFB99 |
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 289 import refusals issued for violation code 3865, affecting 136 unique firms.
When was the most recent refusal for violation 3865?
The most recent import refusal for violation 3865 was on January 20, 2026.
What products are commonly refused for violation 3865?
Products commonly refused under violation 3865 include: CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE), FLAVORED CANDY, HARD (LIVE SAVERS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE), CHOCOLATE CANDY BAR, WITH NUTS OR NUT PRODUCTS (NOT COCONUT). 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.