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Nephron SC, LLC

⚠️ Moderate Risk

FEI: 3010892830 • West Columbia, SC • UNITED STATES

FEI

FEI Number

3010892830

📍

Location

West Columbia, SC

🇺🇸
🏢

Address

4500 12th Street Ext, , West Columbia, SC, United States

Moderate Risk

FDA Import Risk Assessment

45.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
1/10/2022
Latest Refusal
5/19/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
4.9×20%
Frequency
18.2×10%
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

753×

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
1/10/2022
63BDY26IPRATROPIUM BROMIDE (BRONCHODILATOR)
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/10/2022
61EDY04BUDESONIDE (ANTI-ASTHMATIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/19/2020
63BDL02ALBUTEROL SULFATE (BRONCHODILATOR)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Nephron SC, LLC's FDA import refusal history?

Nephron SC, LLC (FEI: 3010892830) has 3 FDA import refusal record(s) in our database, spanning from 5/19/2020 to 1/10/2022.

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. Nephron SC, LLC's FEI number is 3010892830.

What types of violations has Nephron SC, LLC received?

Nephron SC, LLC 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 Nephron SC, LLC come from?

All FDA import refusal data for Nephron SC, LLC 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.