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Laboratorio A. H. Robins Int'L

⚠️ Moderate Risk

FEI: 3004556203 • Cali • COLOMBIA

FEI

FEI Number

3004556203

📍

Location

Cali

🇨🇴

Country

COLOMBIA
🏢

Address

Autopista Cali Yumbo Km 2, , Cali, , Colombia

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/12/2004
Latest Refusal
7/12/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

752×

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
7/12/2004
62FBJ99ANTI-INFECTIVE, TOPICAL N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
7/12/2004
63BBF99BRONCHODILATOR N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laboratorio A. H. Robins Int'L's FDA import refusal history?

Laboratorio A. H. Robins Int'L (FEI: 3004556203) has 2 FDA import refusal record(s) in our database, spanning from 7/12/2004 to 7/12/2004.

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. Laboratorio A. H. Robins Int'L's FEI number is 3004556203.

What types of violations has Laboratorio A. H. Robins Int'L received?

Laboratorio A. H. Robins Int'L 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 Laboratorio A. H. Robins Int'L come from?

All FDA import refusal data for Laboratorio A. H. Robins Int'L 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.