Bioquifar Pharmaceutica Sa Cr
⚠️ Moderate Risk
FEI: 3011572663 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3011572663
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Carrera 37a 25-52, , Bogota, Cundinamarca, 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 |
|---|---|---|---|
| 7/8/2020 | 61JCY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/15/2019 | 66SDY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/14/2016 | 61WCA45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Bioquifar Pharmaceutica Sa Cr's FDA import refusal history?
Bioquifar Pharmaceutica Sa Cr (FEI: 3011572663) has 3 FDA import refusal record(s) in our database, spanning from 10/14/2016 to 7/8/2020.
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. Bioquifar Pharmaceutica Sa Cr's FEI number is 3011572663.
What types of violations has Bioquifar Pharmaceutica Sa Cr received?
Bioquifar Pharmaceutica Sa Cr 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 Bioquifar Pharmaceutica Sa Cr come from?
All FDA import refusal data for Bioquifar Pharmaceutica Sa Cr 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.