BIENVENIDO DIROCHE GUTIERREZ
⚠️ High Risk
FEI: 3013125060 • Santo Domingo • DOMINICAN REPUBLIC
FEI Number
3013125060
Location
Santo Domingo
Country
DOMINICAN REPUBLICAddress
Calle 3ra No 11 La Espe, , Santo Domingo, , Dominican Republic
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/25/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 72NEW VET DR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BIENVENIDO DIROCHE GUTIERREZ's FDA import refusal history?
BIENVENIDO DIROCHE GUTIERREZ (FEI: 3013125060) has 11 FDA import refusal record(s) in our database, spanning from 11/25/2019 to 11/25/2019.
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. BIENVENIDO DIROCHE GUTIERREZ's FEI number is 3013125060.
What types of violations has BIENVENIDO DIROCHE GUTIERREZ received?
BIENVENIDO DIROCHE GUTIERREZ has been cited for 2 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 BIENVENIDO DIROCHE GUTIERREZ come from?
All FDA import refusal data for BIENVENIDO DIROCHE GUTIERREZ 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.