Laboratories Axioma
⚠️ Moderate Risk
FEI: 3005397084 • Bogota • 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/2/2005 | 60SCA06BISMUTH (ANTACID) | New Orleans District Office (NOL-DO) | |
| 11/2/2005 | 61XCA05CARBINOXAMINE MALEATE (ANTI-HISTAMINIC) | New Orleans District Office (NOL-DO) | |
| 11/2/2005 | 60SCA06BISMUTH (ANTACID) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratories Axioma's FDA import refusal history?
Laboratories Axioma (FEI: 3005397084) has 3 FDA import refusal record(s) in our database, spanning from 11/2/2005 to 11/2/2005.
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. Laboratories Axioma's FEI number is 3005397084.
What types of violations has Laboratories Axioma received?
Laboratories Axioma has been cited for 3 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 Laboratories Axioma come from?
All FDA import refusal data for Laboratories Axioma 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.