Violation Code: 265
FDA Violation
Charge Code: SUBSTITUTE
Violation Details
- Violation Code (ASC ID)
- 265
- Charge Code
- SUBSTITUTE
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears that a substance has been substituted wholly or in part for one or more of the article's ingredients.
- Legal Section
- 402(b)(2), 801(a)(3); ADULTERATION
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 9/17/2025 | BUTTER OIL 09AGT02 | |
| 7/31/2025 | HONEY 36CGT04 | |
| 7/31/2025 | HONEY 36CGT04 | |
| 5/21/2025 | HONEY 36CHT04 | |
| 3/6/2025 | SAFFRON, WHOLE (SPICE) 28AGT40 | L. Dometita & Sons Food IndustriesPHILIPPINE |
| 1/14/2025 | LEMON, CITRUS FRUIT JUICES OR CONCENTRATES 20KGT04 | |
| 7/31/2024 | HONEY 36CCT04 | |
| 7/9/2024 | SAFFRON, GROUND, CRACKED (SPICE) 28BET40 | |
| 6/7/2024 | HONEY 36CGT04 | EMPACADORA DE MIEL GDLMEXICO |
| 6/7/2024 | HONEY 36CGT04 | EMPACADORA DE MIEL GDLMEXICO |
| 6/4/2024 | HONEY 36CGT04 | EMPACADORA DE MIEL GDLMEXICO |
| 6/4/2024 | HONEY 36CGT04 | EMPACADORA DE MIEL GDLMEXICO |
| 4/24/2024 | LEMON, CITRUS FRUIT JUICES OR CONCENTRATES 20KHD04 | |
| 2/7/2024 | LEMON, CITRUS FRUIT JUICES OR CONCENTRATES 20KDT04 | |
| 12/19/2023 | LEMON, CITRUS FRUIT JUICES OR CONCENTRATES 20KGT04 | Spice NestINDIA |
Frequently Asked Questions
What is FDA violation code 265?
265 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 that a substance has been substituted wholly or in part for one or more of the article's ingredients.". This violation is based on 402(b)(2), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 265?
According to FDA Import Refusal data, there have been 226 import refusals issued for violation code 265, affecting 78 unique firms.
When was the most recent refusal for violation 265?
The most recent import refusal for violation 265 was on September 17, 2025.
What products are commonly refused for violation 265?
Products commonly refused under violation 265 include: BUTTER OIL, HONEY, SAFFRON, WHOLE (SPICE). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 265?
Violation code 265 is based on 402(b)(2), 801(a)(3); ADULTERATION 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.