Violation Code: 3621
FDA Violation
Charge Code: JUICEHACCP
Violation Details
- Violation Code (ASC ID)
- 3621
- Charge Code
- JUICEHACCP
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed, or held under insanitary conditions, or it may be injurious to health, due to failure of the foreign processor to comply with 21 CFR 120.
- Legal Section
- 801(a)(3);402(a)(4)
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/21/2025 | PLUM, JUICE, PIT FRUIT JUICES OR CONCENTRATES 21KHT14 | Slowfood Corporation Ltd.SOUTH KORE |
| 10/28/2025 | SUBTROPICAL/TROPICAL FRUIT PULP, N.E.C. 21XGD99 | Agro HidroPERU |
| 8/27/2025 | LEMON, CITRUS FRUIT JUICES OR CONCENTRATES 20KGT04 | |
| 8/27/2025 | LEMON, CITRUS FRUIT JUICES OR CONCENTRATES 20KGT04 | |
| 8/27/2025 | LEMON, CITRUS FRUIT JUICES OR CONCENTRATES 20KGT04 | |
| 8/20/2025 | LEMON, CITRUS FRUIT JUICES OR CONCENTRATES 20KHT04 | |
| 1/4/2022 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS 21VGT48 | CB COCONUTS CO.LTD.THAILAND |
| 12/11/2021 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS 21VGT48 | CB COCONUTS CO.LTD.THAILAND |
| 11/3/2021 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS 21VGT48 | CB COCONUTS CO.LTD.THAILAND |
| 5/3/2021 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT, JUICES, MILK, CREME, DRINKS AND NECTARS 21VYY48 | Jaindi Export (PVT)LtdSRI LANKA |
| 11/13/2019 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT PULP 21XGD48 | |
| 6/11/2019 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT 21SYD48 | |
| 8/22/2018 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT 21SCT48 | Jaindi Export (PVT)LtdSRI LANKA |
| 8/22/2018 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT 21SYD48 | |
| 8/22/2018 | COCONUT, SUBTROPICAL AND TROPICAL FRUIT 21SYD48 |
Frequently Asked Questions
What is FDA violation code 3621?
3621 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 to have been prepared, packed, or held under insanitary conditions, or it may be injurious to health, due to failure of the foreign processor to comply with 21 CFR 120.". This violation is based on 801(a)(3);402(a)(4) of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3621?
According to FDA Import Refusal data, there have been 191 import refusals issued for violation code 3621, affecting 20 unique firms.
When was the most recent refusal for violation 3621?
The most recent import refusal for violation 3621 was on November 21, 2025.
What products are commonly refused for violation 3621?
Products commonly refused under violation 3621 include: PLUM, JUICE, PIT FRUIT JUICES OR CONCENTRATES, SUBTROPICAL/TROPICAL FRUIT PULP, N.E.C., LEMON, CITRUS FRUIT JUICES OR CONCENTRATES. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3621?
Violation code 3621 is based on 801(a)(3);402(a)(4) 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.