Astrazeneca Colombia Sa
⚠️ High Risk
FEI: 3008263214 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3008263214
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Carrera 7 71 21, , Bogota, Cundinamarca, 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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/6/2025 | 66NDB03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/14/2023 | 64LCS61TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/27/2020 | 77KCOINHALER, NASAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Astrazeneca Colombia Sa's FDA import refusal history?
Astrazeneca Colombia Sa (FEI: 3008263214) has 3 FDA import refusal record(s) in our database, spanning from 5/27/2020 to 6/6/2025.
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. Astrazeneca Colombia Sa's FEI number is 3008263214.
What types of violations has Astrazeneca Colombia Sa received?
Astrazeneca Colombia Sa has been cited for 2 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 Astrazeneca Colombia Sa come from?
All FDA import refusal data for Astrazeneca Colombia Sa 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.