Jorge Alberto Caro
⚠️ High Risk
FEI: 3009914912 • Santa Fe De Bogotasanta Fe De Bogota • COLOMBIA
FEI Number
3009914912
Location
Santa Fe De Bogotasanta Fe De Bogota
Country
COLOMBIAAddress
Cr 32 # 4 Sur 67, , Santa Fe De Bogotasanta Fe De Bogota, , Colombia
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2013 | 64BCY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/22/2013 | 62GCY46KETOPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/22/2013 | 66SCY36VERAPAMIL (VASODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/22/2013 | 61JCY12LOVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/22/2013 | 62OCY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/22/2013 | 62ACY04CALCITRIOL (ANTI-HYPERCALCEMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/22/2013 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Jorge Alberto Caro's FDA import refusal history?
Jorge Alberto Caro (FEI: 3009914912) has 7 FDA import refusal record(s) in our database, spanning from 1/22/2013 to 1/22/2013.
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. Jorge Alberto Caro's FEI number is 3009914912.
What types of violations has Jorge Alberto Caro received?
Jorge Alberto Caro 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 Jorge Alberto Caro come from?
All FDA import refusal data for Jorge Alberto Caro 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.