ABBOTT LABORATORIES COLOMBIA
⚠️ High Risk
FEI: 3012502359 • Bogota • COLOMBIA
FEI Number
3012502359
Location
Bogota
Country
COLOMBIAAddress
Calle 100 NO 9 A-45 Piso, , 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 |
|---|---|---|---|
| 4/10/2025 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2024 | 64GCY19ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2024 | 61MCY99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/26/2021 | 61JDE09FENOFIBRATE (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2021 | 62GDA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/26/2019 | 62VCO29IMIQUIMOD (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/27/2019 | 61MDA38LAMOTRIGINE (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2019 | 56ICA99MACROLIDE, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/14/2018 | 65UCY04POLIDOCANOL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ABBOTT LABORATORIES COLOMBIA's FDA import refusal history?
ABBOTT LABORATORIES COLOMBIA (FEI: 3012502359) has 9 FDA import refusal record(s) in our database, spanning from 8/14/2018 to 4/10/2025.
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. ABBOTT LABORATORIES COLOMBIA's FEI number is 3012502359.
What types of violations has ABBOTT LABORATORIES COLOMBIA received?
ABBOTT LABORATORIES COLOMBIA 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 ABBOTT LABORATORIES COLOMBIA come from?
All FDA import refusal data for ABBOTT LABORATORIES COLOMBIA 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.