AUDIFARMA
⚠️ Moderate Risk
FEI: 3016893944 • Barranquilla • COLOMBIA
FEI Number
3016893944
Location
Barranquilla
Country
COLOMBIAAddress
Cra 49c 80209, , Barranquilla, , 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/16/2020 | 66JDA01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 62ODC37IRBESARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 65PDA03TAMSULOSIN HCL (REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 62CDA67EPLERENONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 61PDA66LINAGLIPTIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is AUDIFARMA's FDA import refusal history?
AUDIFARMA (FEI: 3016893944) has 5 FDA import refusal record(s) in our database, spanning from 6/16/2020 to 6/16/2020.
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. AUDIFARMA's FEI number is 3016893944.
What types of violations has AUDIFARMA received?
AUDIFARMA 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 AUDIFARMA come from?
All FDA import refusal data for AUDIFARMA 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.