Antonio Llanes
⚠️ Moderate Risk
FEI: 3003904507 • Santo Domingo De Guzman, Distrito Nacional • DOMINICAN REPUBLIC
FEI Number
3003904507
Location
Santo Domingo De Guzman, Distrito Nacional
Country
DOMINICAN REPUBLICAddress
Unknown Street, , Santo Domingo De Guzman, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2003 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Antonio Llanes's FDA import refusal history?
Antonio Llanes (FEI: 3003904507) has 1 FDA import refusal record(s) in our database, spanning from 1/31/2003 to 1/31/2003.
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. Antonio Llanes's FEI number is 3003904507.
What types of violations has Antonio Llanes received?
Antonio Llanes has been cited for 1 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 Antonio Llanes come from?
All FDA import refusal data for Antonio Llanes 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.