Macrolab Asociados Ltda.
⚠️ Moderate Risk
FEI: 3004083336 • Medellin • COLOMBIA
FEI Number
3004083336
Location
Medellin
Country
COLOMBIAAddress
Carrera 48 No. 48 sur 75, local 152 Envigado, Medellin, , 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/26/2024 | 76JESFLOSS, DENTAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Macrolab Asociados Ltda.'s FDA import refusal history?
Macrolab Asociados Ltda. (FEI: 3004083336) has 1 FDA import refusal record(s) in our database, spanning from 3/26/2024 to 3/26/2024.
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. Macrolab Asociados Ltda.'s FEI number is 3004083336.
What types of violations has Macrolab Asociados Ltda. received?
Macrolab Asociados Ltda. 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 Macrolab Asociados Ltda. come from?
All FDA import refusal data for Macrolab Asociados Ltda. 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.