Abbot Labs
⚠️ Moderate Risk
FEI: 3004658802 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3004658802
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Av el dorado 96 10, , 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
Frequently Asked Questions
What is Abbot Labs's FDA import refusal history?
Abbot Labs (FEI: 3004658802) has 2 FDA import refusal record(s) in our database, spanning from 10/21/2004 to 10/21/2004.
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 Labs's FEI number is 3004658802.
What types of violations has Abbot Labs received?
Abbot Labs 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 Abbot Labs come from?
All FDA import refusal data for Abbot Labs 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.