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GRUPO MACARSA SAS

⚠️ Moderate Risk

FEI: 3016720508 • Medellin, Antioquia • COLOMBIA

FEI

FEI Number

3016720508

📍

Location

Medellin, Antioquia

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 30 46 33, , Medellin, Antioquia, Colombia

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
11/19/2020
Latest Refusal
11/19/2020
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
11/19/2020
73KHAMASK, SCAVENGING
237NO PMA
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GRUPO MACARSA SAS's FDA import refusal history?

GRUPO MACARSA SAS (FEI: 3016720508) has 1 FDA import refusal record(s) in our database, spanning from 11/19/2020 to 11/19/2020.

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. GRUPO MACARSA SAS's FEI number is 3016720508.

What types of violations has GRUPO MACARSA SAS received?

GRUPO MACARSA SAS 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 GRUPO MACARSA SAS come from?

All FDA import refusal data for GRUPO MACARSA SAS 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.