UNKNOWN
⚠️ Moderate Risk
FEI: 3004121516 • UNKNOWN • DOMINICAN REPUBLIC
FEI Number
3004121516
Location
UNKNOWN
Country
DOMINICAN REPUBLICAddress
UNKNOWN, , UNKNOWN, , 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
LACKS FIRM
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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 10/15/2020 | 54AMB90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 320LACKS FIRM | Division of Southeast Imports (DSEI) |
| 10/15/2020 | 54AMH01VITAMIN A | 320LACKS FIRM | Division of Southeast Imports (DSEI) |
| 10/15/2020 | 60ZKR26PIPERAZINE CITRATE (ANTIPARASITIC) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 9/16/2003 | 60LCA14CARBAMAZEPINE (ANALGESIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is UNKNOWN's FDA import refusal history?
UNKNOWN (FEI: 3004121516) has 4 FDA import refusal record(s) in our database, spanning from 9/16/2003 to 10/15/2020.
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. UNKNOWN's FEI number is 3004121516.
What types of violations has UNKNOWN received?
UNKNOWN has been cited for 3 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 UNKNOWN come from?
All FDA import refusal data for UNKNOWN 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.