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Aptalis Pharma

⚠️ Moderate Risk

FEI: 3009069882 • Hoover, AL • UNITED STATES

FEI

FEI Number

3009069882

📍

Location

Hoover, AL

🇺🇸
🏢

Address

22 Inverness Center Pkwy, , Hoover, AL, United States

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/25/2013
Latest Refusal
10/25/2013
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1791×

AGR RX

The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.

Refusal History

DateProductViolationsDivision
10/25/2013
60SDL26SUCRALFATE (ANTACID)
179AGR RX
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Aptalis Pharma's FDA import refusal history?

Aptalis Pharma (FEI: 3009069882) has 1 FDA import refusal record(s) in our database, spanning from 10/25/2013 to 10/25/2013.

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. Aptalis Pharma's FEI number is 3009069882.

What types of violations has Aptalis Pharma received?

Aptalis Pharma 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 Aptalis Pharma come from?

All FDA import refusal data for Aptalis Pharma 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.