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•United States

Nephron Sc Inc, West Columbia, SC – FDA Inspections

Inspection records and compliance data for Nephron Sc Inc in West Columbia, South Carolina. 13 FDA inspections on record (3 OAI), 7 Form 483s, 2 warning letters, last inspected August 22, 2025.

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Company Profile

This profile covers Nephron Sc Inc based in West Columbia, South Carolina, United States.

FDA Inspection History

FDA inspections
13
OAI
3
VAI
3
NAI
5
Unclassified
2
Form 483s
7
Warning letters
2

First inspected March 12, 2015. Last inspected August 22, 2025.

Most cited issue areas

  • Validation lacking for sterile drug products4 inspections
  • Air Supply3 inspections
  • Environmental Monitoring System3 inspections

FDA inspections (13)

DateResultFDA center(s)Insp. #
August 22, 2025Not classifiedHuman Drugs · Drug Quality Assurance1274364
September 25, 2024Not classifiedHuman Drugs · Drug Quality Assurance1247772
February 9, 2024OAIHuman Drugs · Drug Quality Assurance1229051
February 10, 2023OAIHuman Drugs · Drug Quality Assurance1197994
April 20, 2022OAIHuman Drugs · Drug Quality Assurance1168119
June 7, 2019NAIHuman Drugs · Drug Quality Assurance1099348
November 14, 2018VAIHuman Drugs · Drug Quality Assurance1071620
July 17, 2018NAIMedical Devices & Rad Health · Compliance: Devices1068875
April 20, 2018VAIHuman Drugs · Drug Quality Assurance1049382
April 21, 2017VAIHuman Drugs · Drug Quality Assurance1015133
January 20, 2017NAIHuman Drugs · Generic Drug Evaluation1006544
December 9, 2016NAIHuman Drugs · Bioresearch Monitoring1002165
March 12, 2015NAIHuman Drugs · Drug Quality Assurance927728
FDA documents

Form 483s (2)

  • Form 483s · August 22, 2025
  • Form 483s · April 20, 2022

Warning Letters (2)

  • Warning Letters · April 20, 2022
  • Warning Letters · September 22, 2020
People (4)
Robert Dean
Person
Brandon C. Heitmeier
Person
Demario L. Walls
Person
Frances de Jesus
Person
Related Companies (10)

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United Therapeutics Corporation
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Actavis Laboratories UT, Inc.
Abraxis Bioscience, LLC
Tulex Pharmaceuticals Inc.
Company Information

Name

Nephron Sc Inc

FEI Number

3010892830

Address

4500 12th Street Ext, West Columbia, South Carolina 29172, United States

Country

United States

ID: 2dadfd52-37b7-4da6-9885-864d470c1b18

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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