Dario Cuellar Dias
⚠️ Moderate Risk
FEI: 3011923002 • Cali, Valle Del Cauca • COLOMBIA
FEI Number
3011923002
Location
Cali, Valle Del Cauca
Country
COLOMBIAAddress
Calle 27 3 32 B 04 El Jardin, , Cali, Valle Del Cauca, Colombia
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 |
|---|---|---|---|
| 12/17/2015 | 62GBA41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/17/2015 | 62OBA44METOPROLOL TARTRATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/17/2015 | 66SBY27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Dario Cuellar Dias's FDA import refusal history?
Dario Cuellar Dias (FEI: 3011923002) has 3 FDA import refusal record(s) in our database, spanning from 12/17/2015 to 12/17/2015.
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. Dario Cuellar Dias's FEI number is 3011923002.
What types of violations has Dario Cuellar Dias received?
Dario Cuellar Dias 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 Dario Cuellar Dias come from?
All FDA import refusal data for Dario Cuellar Dias 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.