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Du Pont Merck Pharma

⚠️ Moderate Risk

FEI: 1000571794 • Manati, PR • UNITED STATES

FEI

FEI Number

1000571794

📍

Location

Manati, PR

🇺🇸
🏢

Address

P.O.Box 30100, , Manati, PR, United States

Moderate Risk

FDA Import Risk Assessment

37.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
7/10/2003
Latest Refusal
6/24/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1795×

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
7/10/2003
60LCK37NALBUPHINE HCL (ANALGESIC)
179AGR RX
Seattle District Office (SEA-DO)
7/10/2003
60LCK37NALBUPHINE HCL (ANALGESIC)
179AGR RX
Seattle District Office (SEA-DO)
7/10/2003
60LCK37NALBUPHINE HCL (ANALGESIC)
179AGR RX
Seattle District Office (SEA-DO)
7/10/2003
60LCK99ANALGESIC, N.E.C.
179AGR RX
Seattle District Office (SEA-DO)
6/24/2003
60LCK99ANALGESIC, N.E.C.
179AGR RX
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Du Pont Merck Pharma's FDA import refusal history?

Du Pont Merck Pharma (FEI: 1000571794) has 5 FDA import refusal record(s) in our database, spanning from 6/24/2003 to 7/10/2003.

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. Du Pont Merck Pharma's FEI number is 1000571794.

What types of violations has Du Pont Merck Pharma received?

Du Pont Merck 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 Du Pont Merck Pharma come from?

All FDA import refusal data for Du Pont Merck 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.