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PRODUCTOS RAS SAS

⚠️ Moderate Risk

FEI: 3014394196 • Medellin, Antioquia • COLOMBIA

FEI

FEI Number

3014394196

📍

Location

Medellin, Antioquia

🇨🇴

Country

COLOMBIA
🏢

Address

Clle 44 73-20, , Medellin, Antioquia, Colombia

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
6/22/2018
Latest Refusal
6/22/2018
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

3421×

PERSONALRX

The article appears to be a drug which requires a prescription from your doctor.

35001×

RXLABEL

The labeling fails to bear, at a minimum, the symbol "RX Only".

Refusal History

DateProductViolationsDivision
6/22/2018
60XDL23TIMOLOL MALEATE (ANTI-ADRENERGIC)
118NOT LISTED
342PERSONALRX
3500RXLABEL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PRODUCTOS RAS SAS's FDA import refusal history?

PRODUCTOS RAS SAS (FEI: 3014394196) has 1 FDA import refusal record(s) in our database, spanning from 6/22/2018 to 6/22/2018.

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. PRODUCTOS RAS SAS's FEI number is 3014394196.

What types of violations has PRODUCTOS RAS SAS received?

PRODUCTOS RAS SAS 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 PRODUCTOS RAS SAS come from?

All FDA import refusal data for PRODUCTOS RAS 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.