Serrana Agroindustrial S.R.L
⚠️ Moderate Risk
FEI: 3005008096 • D.N., Distrito Nacional • DOMINICAN REPUBLIC
FEI Number
3005008096
Location
D.N., Distrito Nacional
Country
DOMINICAN REPUBLICAddress
Juan de Morfa No. 93, , Santo Domingo, D.N., Distrito Nacional, Dominican Republic
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
COUMARIN
The article appears to bear or contain Coumarin, a poisonous or deleterious substance, which may render it injurious to health.
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/21/2016 | 28CGT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | Florida District Office (FLA-DO) |
| 10/21/2016 | 28CGT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | Florida District Office (FLA-DO) |
| 10/21/2016 | 28CGT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | Florida District Office (FLA-DO) |
| 5/13/2016 | 28CHT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | San Juan District Office (SJN-DO) |
| 5/13/2016 | 28CHT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | San Juan District Office (SJN-DO) |
| 5/13/2016 | 28CHT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | San Juan District Office (SJN-DO) |
| 5/13/2016 | 28CHT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | San Juan District Office (SJN-DO) |
| 5/13/2016 | 28CHT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | San Juan District Office (SJN-DO) |
| 5/13/2016 | 28CHT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | San Juan District Office (SJN-DO) |
| 2/3/2016 | 28MGT04VANILLA (VANILLIN) IMITATION FLAVOR | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 2/3/2016 | 28MGT04VANILLA (VANILLIN) IMITATION FLAVOR | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 2/3/2016 | 28MGT04VANILLA (VANILLIN) IMITATION FLAVOR | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 2/3/2016 | 28MGT04VANILLA (VANILLIN) IMITATION FLAVOR | 218LIST INGRE | San Juan District Office (SJN-DO) |
| 12/1/2014 | 28MGT04VANILLA (VANILLIN) IMITATION FLAVOR | 238UNSAFE ADD | San Juan District Office (SJN-DO) |
| 11/2/2012 | 28CCY51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | Florida District Office (FLA-DO) |
| 6/29/2009 | 28CCT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | San Juan District Office (SJN-DO) |
| 1/13/2009 | 28CHT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | 2080COUMARIN | Florida District Office (FLA-DO) |
| 12/8/2003 | 28MGY04VANILLA (VANILLIN) IMITATION FLAVOR | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Serrana Agroindustrial S.R.L's FDA import refusal history?
Serrana Agroindustrial S.R.L (FEI: 3005008096) has 18 FDA import refusal record(s) in our database, spanning from 12/8/2003 to 10/21/2016.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Serrana Agroindustrial S.R.L's FEI number is 3005008096.
What types of violations has Serrana Agroindustrial S.R.L received?
Serrana Agroindustrial S.R.L has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Serrana Agroindustrial S.R.L come from?
All FDA import refusal data for Serrana Agroindustrial S.R.L is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.