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Ruben Yusep Guzman Cl Cl

⚠️ Moderate Risk

FEI: 3009472202 • Santa Fe De Bogotasanta Fe De Bogota • COLOMBIA

FEI

FEI Number

3009472202

📍

Location

Santa Fe De Bogotasanta Fe De Bogota

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 34a # 15-29 Palmiradeprisa -, , Santa Fe De Bogotasanta Fe De Bogota, , Colombia

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/23/2012
Latest Refusal
4/23/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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
4/23/2012
62OCY28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Ruben Yusep Guzman Cl Cl's FDA import refusal history?

Ruben Yusep Guzman Cl Cl (FEI: 3009472202) has 1 FDA import refusal record(s) in our database, spanning from 4/23/2012 to 4/23/2012.

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. Ruben Yusep Guzman Cl Cl's FEI number is 3009472202.

What types of violations has Ruben Yusep Guzman Cl Cl received?

Ruben Yusep Guzman Cl Cl 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 Ruben Yusep Guzman Cl Cl come from?

All FDA import refusal data for Ruben Yusep Guzman Cl Cl 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.