Violation Code: 3878
FDA Violation
Charge Code: POISONORD
Violation Details
- Violation Code (ASC ID)
- 3878
- Charge Code
- POISONORD
- Description
- The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance which would ordinarily render the article injurious to health. Contains:
- Legal Section
- 402(a)(1), 801(a)(3); ADULTERATION
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | PESCAMOZ LDA | Beira, MOZAMBIQUE | 17 |
| 2 | Viral Corporation | Lodhika, INDIA | 17 |
| 3 | DHARA FOODS PVT .LTD | Anand, INDIA | 17 |
| 4 | Peekay International Inc. | Maspeth, UNITED STA | 10 |
| 5 | SOCIETE DE CONSERVERIE EN AFRIQUE (SCA S.A.) | Dakar, SENEGAL | 10 |
| 6 | ABHAYA EXPORTS (PVT) LTD. | Navi Mumbai, INDIA | 9 |
| 7 | J R SHAH | Gujarat., INDIA | 9 |
| 8 | Unique Fragrances | New Delhi, INDIA | 9 |
| 9 | PT. Winson Prima Sejahtera | Medan, INDONESIA | 8 |
| 10 | Unique Fragrances | Sonepat, INDIA | 8 |
| 11 | HAI PHU SEAFOOD ONE MEMBER EXPORT IMPORT LIMITED | Quang Ngai, VIETNAM | 7 |
| 12 | KEVAL EXPORTS PVT LTD | Navi Mumbai, INDIA | 7 |
| 13 | Taprobane Seafood (PVT) LTD. | Dankotuwa, SRI LANKA | 7 |
| 14 | PT Dharma Samudera Fishing Industries TBK | Jakarta, INDONESIA | 6 |
| 15 | M/S SANCHI ENTERPRISE | Siliguri, INDIA | 6 |
| 16 | RUNGCHAI CO | Chiang Mai, THAILAND | 6 |
| 17 | Farhan Agro Processor | Narayanganj, BANGLADESH | 6 |
| 18 | Pt. Bahari Prima Manunggal | Jakarta Barat, INDONESIA | 5 |
| 19 | OVIJAT FOOD & BEVERAGE INDUSTRIES LTD | Dhaka, BANGLADESH | 5 |
| 20 | SAN CARLOS BLUE CRAB S.A. DE C.V. | Rancho O Rancheria Centro, MEXICO | 5 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 1/21/2026 | BETEL NUT, IN SHELL 23AYY14 | CHAICHADA CO., LTD.THAILAND |
| 1/21/2026 | BETEL NUT, IN SHELL 23AYY14 | CHAICHADA CO., LTD.THAILAND |
| 1/12/2026 | BETEL NUT, SHELLED 23BGT14 | |
| 12/31/2025 | BETEL NUT, NUT FLOUR/MEAL 23OGT14 | Global Food Trading Co., Ltd.THAILAND |
| 12/29/2025 | BETEL NUT, IN SHELL 23AYY14 | CS TEAMUNITED KIN |
| 12/29/2025 | BETEL NUT, IN SHELL 23AYT14 | CS TEAMUNITED KIN |
| 12/29/2025 | BETEL NUT, IN SHELL 23AYT14 | CS TEAMUNITED KIN |
| 12/15/2025 | BETEL NUT, SHELLED 23BGT14 | |
| 11/18/2025 | BETEL NUT, IN SHELL 23AYY14 | DP ExportNEPAL |
| 11/18/2025 | BETEL NUT, IN SHELL 23AYY14 | DP ExportNEPAL |
| 11/13/2025 | TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) 16AVE45 | |
| 11/13/2025 | TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) 16AVE45 | |
| 11/13/2025 | TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) 16AVE45 | |
| 11/13/2025 | TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) 16AVE45 | |
| 11/13/2025 | TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.) 16AVE45 |
Related Violations
Other violations under the same legal section: 402(a)(1), 801(a)(3); ADULTERATION
Frequently Asked Questions
What is FDA violation code 3878?
3878 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 contain a poisonous or deleterious substance which would ordinarily render the article injurious to health. Contains:". This violation is based on 402(a)(1), 801(a)(3); ADULTERATION of the Federal Food, Drug, and Cosmetic Act.
How many import refusals have been issued for violation 3878?
According to FDA Import Refusal data, there have been 377 import refusals issued for violation code 3878, affecting 152 unique firms.
When was the most recent refusal for violation 3878?
The most recent import refusal for violation 3878 was on January 21, 2026.
What products are commonly refused for violation 3878?
Products commonly refused under violation 3878 include: BETEL NUT, IN SHELL, BETEL NUT, SHELLED, BETEL NUT, NUT FLOUR/MEAL. These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 3878?
Violation code 3878 is based on 402(a)(1), 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.