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MARIA RUBY MAYOR RIVERA

⚠️ Moderate Risk

FEI: 3014289245 • Bogota, Cundinamarca • COLOMBIA

FEI

FEI Number

3014289245

📍

Location

Bogota, Cundinamarca

🇨🇴

Country

COLOMBIA
🏢

Address

Cra 3 No 64a 106, , Bogota, Cundinamarca, Colombia

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
4/27/2018
Latest Refusal
4/27/2018
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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

DateProductViolationsDivision
4/27/2018
60LCB01ACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
4/27/2018
64SCB29ZOPICLONE
75UNAPPROVED
Division of Southeast Imports (DSEI)
4/27/2018
63HCB01BISACODYL (CATHARTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is MARIA RUBY MAYOR RIVERA's FDA import refusal history?

MARIA RUBY MAYOR RIVERA (FEI: 3014289245) has 3 FDA import refusal record(s) in our database, spanning from 4/27/2018 to 4/27/2018.

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. MARIA RUBY MAYOR RIVERA's FEI number is 3014289245.

What types of violations has MARIA RUBY MAYOR RIVERA received?

MARIA RUBY MAYOR RIVERA 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 MARIA RUBY MAYOR RIVERA come from?

All FDA import refusal data for MARIA RUBY MAYOR RIVERA 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.