AMELIA DEL SOCORRO CALVO BETANCU
⚠️ High Risk
FEI: 3012738183 • Pereira • COLOMBIA
FEI Number
3012738183
Location
Pereira
Country
COLOMBIAAddress
Cra 27 71-27 Cuba, , Pereira, , 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 |
|---|---|---|---|
| 5/22/2018 | 62YCB07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2018 | 64LCK19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2018 | 62TCF02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2018 | 64LCZ41HYDROCORTISONE SODIUM SUCCINATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2018 | 61WAO47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2018 | 64LAO37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2018 | 61EAB08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is AMELIA DEL SOCORRO CALVO BETANCU's FDA import refusal history?
AMELIA DEL SOCORRO CALVO BETANCU (FEI: 3012738183) has 7 FDA import refusal record(s) in our database, spanning from 5/22/2018 to 5/22/2018.
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. AMELIA DEL SOCORRO CALVO BETANCU's FEI number is 3012738183.
What types of violations has AMELIA DEL SOCORRO CALVO BETANCU received?
AMELIA DEL SOCORRO CALVO BETANCU 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 AMELIA DEL SOCORRO CALVO BETANCU come from?
All FDA import refusal data for AMELIA DEL SOCORRO CALVO BETANCU 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.