Violation Code: 3600
FDA Violation
Charge Code: REFUSE EI
Violation Details
- Violation Code (ASC ID)
- 3600
- Charge Code
- REFUSE EI
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
- Legal Section
- 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING
Most Affected Firms
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/22/2026 | TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) 16AYY45 | |
| 1/22/2026 | TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) 16AYY45 | |
| 1/16/2026 | MAHI MAHI 16AGT51 | |
| 1/16/2026 | MAHI MAHI 16AGT51 | |
| 1/16/2026 | MAHI MAHI 16AGT51 | |
| 1/13/2026 | SOYBEANS (SEE INDUSTRY 37 FOR BEAN CURD), DRIED OR PASTE 24BHT13 | GIPEUNSAEM CO.,LTDSOUTH KORE |
| 1/13/2026 | WHEAT, MILLED PRODUCT, N.E.C. 02FMB99 | |
| 1/12/2026 | CHESTNUT, SHELLED 23BGT04 | |
| 1/8/2026 | CHESTNUT, SHELLED 23BCT04 | |
| 12/22/2025 | SAUCES, N.E.C. 37JYT99 | |
| 12/22/2025 | SAUCES, N.E.C. 37JYY99 | |
| 12/22/2025 | SAUCES, N.E.C. 37JYT99 | |
| 12/22/2025 | SAUCES, N.E.C. 37JYY99 | |
| 12/22/2025 | SAUCES, N.E.C. 37JYT99 | |
| 12/22/2025 | SAUCES, N.E.C. 37JYY99 |
Related Violations
Other violations under the same legal section: 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING
| Code | Charge Code | Cases |
|---|---|---|
| 308 | MFR INSAN | 6219 |
Frequently Asked Questions
What is FDA violation code 3600?
3600 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.". This violation is based on 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3600?
According to FDA Import Refusal data, there have been 232 import refusals issued for violation code 3600, affecting 45 unique firms.
When was the most recent refusal for violation 3600?
The most recent import refusal for violation 3600 was on January 22, 2026.
What products are commonly refused for violation 3600?
Products commonly refused under violation 3600 include: TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.), MAHI MAHI. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3600?
Violation code 3600 is based on 801(a)(1); INSANITARY MANUFACTURING, PROCESSING OR PACKING 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.