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Sun Pharmaceutical Industries, LTD.

⚠️ Moderate Risk

FEI: 3011304354 • Wixom, MI • UNITED STATES

FEI

FEI Number

3011304354

📍

Location

Wixom, MI

🇺🇸
🏢

Address

31060 Oak Creek Dr, , Wixom, MI, 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
8/21/2009
Latest Refusal
8/21/2009
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
8/21/2009
63FDA06DIGOXIN (CARDIOTONIC)
179AGR RX
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Sun Pharmaceutical Industries, LTD.'s FDA import refusal history?

Sun Pharmaceutical Industries, LTD. (FEI: 3011304354) has 1 FDA import refusal record(s) in our database, spanning from 8/21/2009 to 8/21/2009.

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. Sun Pharmaceutical Industries, LTD.'s FEI number is 3011304354.

What types of violations has Sun Pharmaceutical Industries, LTD. received?

Sun Pharmaceutical Industries, LTD. 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 Sun Pharmaceutical Industries, LTD. come from?

All FDA import refusal data for Sun Pharmaceutical Industries, LTD. 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.