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Alvaro De Jesus Acosta Ortiz

⚠️ Moderate Risk

FEI: 3007518522 • Medellin • COLOMBIA

FEI

FEI Number

3007518522

📍

Location

Medellin

🇨🇴

Country

COLOMBIA
🏢

Address

Vereda Cabildo Girardota, , Medellin, , 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
6/2/2009
Latest Refusal
6/2/2009
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
6/2/2009
64RCC99HORMONE N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Alvaro De Jesus Acosta Ortiz's FDA import refusal history?

Alvaro De Jesus Acosta Ortiz (FEI: 3007518522) has 1 FDA import refusal record(s) in our database, spanning from 6/2/2009 to 6/2/2009.

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. Alvaro De Jesus Acosta Ortiz's FEI number is 3007518522.

What types of violations has Alvaro De Jesus Acosta Ortiz received?

Alvaro De Jesus Acosta Ortiz 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 Alvaro De Jesus Acosta Ortiz come from?

All FDA import refusal data for Alvaro De Jesus Acosta Ortiz 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.