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•United States

Nephron Sterile Compounding Center LLC, West Columbia, SC – FDA Inspections

Inspection records and compliance data for Nephron Sterile Compounding Center LLC in West Columbia, South Carolina. 9 FDA inspections on record (4 OAI), last inspected April 20, 2022.

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Company Profile

This profile covers Nephron Sterile Compounding Center LLC based in West Columbia, South Carolina, United States.

FDA Inspection History

FDA inspections
9
OAI
4
VAI
2
NAI
3
Form 483s
0
Warning letters
0

First inspected May 18, 2010. Last inspected April 20, 2022.

Most cited issue areas

  • Environmental Monitoring System3 inspections
  • Investigations of discrepancies, failures3 inspections
  • Following/documenting laboratory controls2 inspections

FDA inspections (9)

DateResultFDA center(s)Insp. #
April 20, 2022OAIHuman Drugs · Drug Quality Assurance1167490
November 15, 2019VAIHuman Drugs · Drug Quality Assurance1109980
July 6, 2016NAIHuman Drugs · Drug Quality Assurance984347
August 14, 2015OAIHuman Drugs, Medical Devices & Rad Health · Drug Quality Assurance938418
November 13, 2014NAIHuman Drugs · Drug Quality Assurance905361
February 21, 2014OAIHuman Drugs, Medical Devices & Rad Health · Unapproved and Misbranded Drugs868313
August 17, 2012VAIHuman Drugs, Medical Devices & Rad Health · Compliance: Devices795087
June 17, 2011OAIHuman Drugs · Postmarket Surv. and Epidemiology731152
May 18, 2010NAIHuman Drugs · Bioresearch Monitoring662081
FDA documents

Form 483s (7)

  • Form 483s · September 25, 2024
  • Form 483s · February 10, 2023
  • Form 483s · April 20, 2022
  • Form 483s · November 15, 2019
  • Form 483s · April 20, 2018
  • Form 483s · April 21, 2017
  • Form 483s · July 6, 2016

EIRs (1)

  • EIRs · April 21, 2017
People (4)
Postelle Birch-Smith, CSO
Person
Narong Chamkasem, Chemist
Person
Rachael L. Cook
Person
Bonita S. Chester
Person
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Universal Packaging Systems, Inc.
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Beutlich Pharmaceuticals LLC
Company Information

Name

Nephron Sterile Compounding Center LLC

FEI Number

3011158388

Address

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

Country

United States

ID: b9848542-bf88-4696-80c3-5fc545b76a92

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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
info@keypedia.com
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