Violation Code: 2080
FDA Violation
Charge Code: COUMARIN
Violation Details
- Violation Code (ASC ID)
- 2080
- Charge Code
- COUMARIN
- Description
- The article appears to bear or contain Coumarin, a poisonous or deleterious substance, which may render it injurious to health.
- Legal Section
- 402(a)(1), 801(a)(3), Adulteration
Most Affected Firms
| # | Firm Name | Location | Cases |
|---|---|---|---|
| 1 | Serrana Agroindustrial S.R.L | D.N., DOMINICAN | 13 |
| 2 | Industrias Alimenticias "Dona Tina" | Managua, NICARAGUA | 10 |
| 3 | P.A. Benjamin Manufacturing Company Limited | Kingston, JAMAICA | 10 |
| 4 | Procesadora Vizcaya, C por A | Santo Domingo, DOMINICAN | 9 |
| 5 | Pharmacie Vital - Herne | Port-Au-Prince, HAITI | 3 |
| 6 | Exportaciones San Miguell | San Salvador, EL SALVADO | 3 |
| 7 | Productos Oriente, C. por A. | Santo Domingo, DOMINICAN | 2 |
| 8 | Inpack Food Products Limited | Caroni, TRINIDAD A | 2 |
| 9 | Industrias Guiguena , C.X.A. | Dominican Republic, DOMINICAN | 2 |
| 10 | SONAPROD | Port-Au-Prince, HAITI | 1 |
| 11 | Transcend Organization World Opportunity- Haiti | Port-Au-Prince, HAITI | 1 |
| 12 | Twins Manufacturing Chemists | Ruimveldt, GUYANA | 1 |
| 13 | VANILLA MEX (Jose Fco. Mendoza Ordonez) | San Nicolas De Los Garza, MEXICO | 1 |
| 14 | Damis Maxaint | Port-Au-Prince, HAITI | 1 |
| 15 | Xiame S.A. De C.V. | Ciudad De Mexico, MEXICO | 1 |
| 16 | Dr. Evans Scott | Port-Au-Prince, HAITI | 1 |
| 17 | Emmanuel Evans Scott | Santo Domingo, DOMINICAN | 1 |
| 18 | Ines Aguiar | Santo Domingo, DOMINICAN | 1 |
| 19 | Jean Raphael Lamarque | Port-Au-Prince, HAITI | 1 |
| 20 | Labcoval | unknown, HAITI | 1 |
Recent Import Refusals
| Date | Product | Firm |
|---|---|---|
| 11/19/2025 | VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) 28CHT51 | Procesadora Vizcaya, C por ADOMINICAN |
| 11/19/2025 | VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) 28CHT51 | Procesadora Vizcaya, C por ADOMINICAN |
| 10/31/2025 | VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) 28CGT51 | Industrias Alimenticias "Dona Tina"NICARAGUA |
| 1/12/2023 | VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) 28CYT51 | |
| 8/23/2019 | VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) 28CCY51 | |
| 11/19/2018 | VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) 28CCT51 | |
| 6/2/2017 | VANILLA BEAN, RAW MATERIAL FOR EXTRACTS AND FLAVORS 28NGT03 | Industrias Alimenticias "Dona Tina"NICARAGUA |
| 5/9/2017 | VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) 28CCT51 | Productos Oriente, C. por A.DOMINICAN |
| 3/20/2017 | VANILLA BEAN, RAW MATERIAL FOR EXTRACTS AND FLAVORS 28NCT03 | Industrias Alimenticias "Dona Tina"NICARAGUA |
| 12/1/2016 | IMITATION FLAVOR, N.E.C. 28MCT99 | Inpack Food Products LimitedTRINIDAD A |
| 12/1/2016 | IMITATION FLAVOR, N.E.C. 28MCT99 | Inpack Food Products LimitedTRINIDAD A |
| 11/8/2016 | VANILLA BEAN, RAW MATERIAL FOR EXTRACTS AND FLAVORS 28NGT03 | Industrias Alimenticias "Dona Tina"NICARAGUA |
| 10/21/2016 | VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) 28CGT51 | Serrana Agroindustrial S.R.LDOMINICAN |
| 10/21/2016 | VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) 28CGT51 | Serrana Agroindustrial S.R.LDOMINICAN |
| 10/21/2016 | VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) 28CGT51 | Serrana Agroindustrial S.R.LDOMINICAN |
Related Violations
Other violations under the same legal section: 402(a)(1), 801(a)(3), Adulteration
Frequently Asked Questions
What is FDA violation code 2080?
2080 is an FDA violation code that indicates: "The article appears to bear or contain Coumarin, a poisonous or deleterious substance, which may render it injurious to health.". 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 2080?
According to FDA Import Refusal data, there have been 68 import refusals issued for violation code 2080, affecting 23 unique firms.
When was the most recent refusal for violation 2080?
The most recent import refusal for violation 2080 was on November 19, 2025.
What products are commonly refused for violation 2080?
Products commonly refused under violation 2080 include: VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE). These products were refused entry because they did not meet FDA requirements.
What is the legal basis for FDA violation code 2080?
Violation code 2080 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.