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Genmed SAS Bogota D.C.

⚠️ Moderate Risk

FEI: 3012260997 • Bogota • COLOMBIA

FEI

FEI Number

3012260997

📍

Location

Bogota

🇨🇴

Country

COLOMBIA
🏢

Address

Unknown, , Bogota, , 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
64HBK01BROMHEXINE HCL (EXPECTORANT)
118NOT LISTED
342PERSONALRX
3500RXLABEL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Genmed SAS Bogota D.C.'s FDA import refusal history?

Genmed SAS Bogota D.C. (FEI: 3012260997) 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. Genmed SAS Bogota D.C.'s FEI number is 3012260997.

What types of violations has Genmed SAS Bogota D.C. received?

Genmed SAS Bogota D.C. 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 Genmed SAS Bogota D.C. come from?

All FDA import refusal data for Genmed SAS Bogota D.C. 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.