Violation Code: 2580
FDA Violation
Charge Code: MFRHACCP
Violation Details
- Violation Code (ASC ID)
- 2580
- Charge Code
- MFRHACCP
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).
- Legal Section
- 402(a)(4), 801(a)(3)
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | MAY YU MARINE PRODUCTS CO. LTD | South Dagon T/s, MYANMAR | 152 |
| 2 | Alimentos Prosalud SA | Barranca, COSTA RICA | 80 |
| 3 | Cermaq Chile S.A. No. 10195 | Ancud, CHILE | 42 |
| 4 | NARA CO.,LTD. | Ibusuki, JAPAN | 33 |
| 5 | Fukusui Shoji Ltd. | Fukuoka, JAPAN | 33 |
| 6 | Jeong Hwa Foods Co., Ltd. | Pohang, SOUTH KORE | 30 |
| 7 | Gamma-A SIA | Riga, LATVIA | 29 |
| 8 | I-TAIL CORPORATION PUBLIC COMPANY LIMITED Limited Company | Mueang Songkhla, THAILAND | 24 |
| 9 | JK Fish Co LTD | Nha Trang, VIETNAM | 23 |
| 10 | Tang Sang Hah Co., Ltd. | Mueang Samut Prakan, THAILAND | 22 |
| 11 | NHAT NGUYEN FOODS COMPANY LIMITED | Cam Ranh, VIETNAM | 21 |
| 12 | Yamaki Co., Ltd. | Iyo, JAPAN | 20 |
| 13 | Pan-Am Foods (Pvt) Ltd. | Avissawella, SRI LANKA | 20 |
| 14 | Thai Fishsauce Factory (Squid Brand) Co.,Ltd. | Samut Songkhram, THAILAND | 17 |
| 15 | Superfish S.A. | Kukinia 43, POLAND | 17 |
| 16 | P.T. Bonecom | Jakarta, INDONESIA | 16 |
| 17 | KILIC DENIZ URUNLERI URETIMI IHRACAT ITHALAT VE TICARET ANONIM SIRKETI PAKETLEME SUBESI | Milas, TURKEY | 16 |
| 18 | Superfish | Ustronie, POLAND | 14 |
| 19 | Hang Tai Marine Products Co. | Hong Kong, HONG KONG | 13 |
| 20 | Pt. Berkat Rasa Fajarindo | Jakarta Utara, INDONESIA | 13 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 10/28/2025 | BONITO 16AVD07 | |
| 10/28/2025 | CROAKER 16AVT13 | |
| 10/28/2025 | GOURMAY, GOURAMI 16AVD52 | |
| 10/2/2025 | FISH, N.E.C. 16AGD99 | |
| 9/11/2025 | MULLET 16AGD23 | |
| 9/11/2025 | GOBY 16AGT83 | |
| 9/11/2025 | MACKEREL (ALL EXCEPT SCOMBEROMORUS SP, EG SPANISH OR KING SEE '22') 16AGD73 | |
| 8/20/2025 | CONCENTRATED BROTH, N.E.C. 38NCT99 | |
| 7/21/2025 | CONCENTRATED BROTH, N.E.C. 38NCT99 | |
| 7/21/2025 | ANCHOVY 16AGD01 | Anfele, S.A.SPAIN |
| 7/21/2025 | ANCHOVY 16AGD01 | Anfele, S.A.SPAIN |
| 7/15/2025 | CONCENTRATED BROTH, N.E.C. 38NCT99 | |
| 6/17/2025 | TROUT (RAINBOW, BROOK, BROWN, CHAR, STEELHEAD, ETC.), HOT SMOKED, FISH 16IVT44 | Agustson A/SDENMARK |
| 6/17/2025 | TROUT (RAINBOW, BROOK, BROWN, CHAR, STEELHEAD, ETC.), HOT SMOKED, FISH 16IVT44 | Agustson A/SDENMARK |
| 5/28/2025 | TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) 16AGC45 |
Frequently Asked Questions
What is FDA violation code 2580?
2580 is an FDA violation code that indicates: "The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).". This violation is based on 402(a)(4), 801(a)(3) of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 2580?
According to FDA Import Refusal data, there have been 1290 import refusals issued for violation code 2580, affecting 245 unique firms.
When was the most recent refusal for violation 2580?
The most recent import refusal for violation 2580 was on October 28, 2025.
What products are commonly refused for violation 2580?
Products commonly refused under violation 2580 include: BONITO, CROAKER, GOURMAY, GOURAMI, FISH, N.E.C., MULLET. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2580?
Violation code 2580 is based on 402(a)(4), 801(a)(3) 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.