Abbot Laboratorios De Colombia S.A.
⚠️ High Risk
FEI: 3000283924 • Bogota • COLOMBIA
FEI Number
3000283924
Location
Bogota
Country
COLOMBIAAddress
Avenida Eldorado No. 96-10, , 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2025 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2016 | 61FCC56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/28/2011 | 62VCK31INTERFERON ALFA-2B, RECOMBINANT/RIBAVIRI (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Abbot Laboratorios De Colombia S.A.'s FDA import refusal history?
Abbot Laboratorios De Colombia S.A. (FEI: 3000283924) has 3 FDA import refusal record(s) in our database, spanning from 10/28/2011 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. Abbot Laboratorios De Colombia S.A.'s FEI number is 3000283924.
What types of violations has Abbot Laboratorios De Colombia S.A. received?
Abbot Laboratorios De Colombia S.A. 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 Abbot Laboratorios De Colombia S.A. come from?
All FDA import refusal data for Abbot Laboratorios De Colombia S.A. 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.