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USpharma Ltd

⚠️ Moderate Risk

FEI: 1010370 • Miami Lakes, FL • UNITED STATES

FEI

FEI Number

1010370

📍

Location

Miami Lakes, FL

🇺🇸
🏢

Address

13900 Nw 57th Ct, , Miami Lakes, FL, United States

Moderate Risk

FDA Import Risk Assessment

27.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
9/21/2011
Latest Refusal
9/21/2011
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4734×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
9/21/2011
63HAR25POLYETHYLENE GLYCOL 3350/ELECTROLYTES (CARTHARTIC)
473LABELING
New York District Office (NYK-DO)
9/21/2011
63HAR25POLYETHYLENE GLYCOL 3350/ELECTROLYTES (CARTHARTIC)
473LABELING
New York District Office (NYK-DO)
9/21/2011
63HAR25POLYETHYLENE GLYCOL 3350/ELECTROLYTES (CARTHARTIC)
473LABELING
New York District Office (NYK-DO)
9/21/2011
63HAR25POLYETHYLENE GLYCOL 3350/ELECTROLYTES (CARTHARTIC)
473LABELING
New York District Office (NYK-DO)

Frequently Asked Questions

What is USpharma Ltd's FDA import refusal history?

USpharma Ltd (FEI: 1010370) has 4 FDA import refusal record(s) in our database, spanning from 9/21/2011 to 9/21/2011.

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. USpharma Ltd's FEI number is 1010370.

What types of violations has USpharma Ltd received?

USpharma 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 USpharma Ltd come from?

All FDA import refusal data for USpharma 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.