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Facility profile

Nephron SC, LLC

Testing & analysis · Drug product manufacturing · West Columbia, SC

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

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Due diligence

Regulatory record at a glance

Use these records to guide qualification; they are not a facility score.

Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Aug 22, 2025 · FDA documented observations for voluntary correction.

Matched compliance actions
Warning Letter · Oct 2022

Within five years · review the action and follow-up.

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Shows

Registration status and a latest matched voluntary action indicated inspection.

Doesn’t show

Exact services, availability, capacity, pricing, or overall quality.

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Method and source details
View full inspection and compliance history32 inspection records

FDA inspection history

32 records, May 2010 – Aug 2025 · 7 NAI · 14 VAI · 11 OAI

DateClassProject areaCitationsFY
Aug 22, 2025VAIDrug Quality AssuranceYes2025
Sep 25, 2024OAIDrug Quality AssuranceYes2024
Feb 9, 2024OAIDrug Quality AssuranceYes2024
Feb 10, 2023OAIDrug Quality AssuranceYes2023
Apr 20, 2022OAIDrug Quality Assurance2022
Apr 20, 2022OAIDrug Quality AssuranceYes2022
Nov 15, 2019VAIDrug Quality AssuranceYes2020
Jun 7, 2019NAIDrug Quality Assurance2019
Nov 14, 2018VAIDrug Quality AssuranceYes2019
Jul 17, 2018NAICompliance: Devices2018
Apr 20, 2018VAIDrug Quality AssuranceYes2018
Apr 21, 2017VAIDrug Quality AssuranceYes2017
Jan 20, 2017VAIDrug Quality Assurance2017
Dec 9, 2016NAIBioresearch Monitoring2017
Jul 6, 2016NAIDrug Quality Assurance2016
Aug 14, 2015VAICompliance: Devices2015
Aug 14, 2015VAIPostmarket Assurance: Devices2015
Aug 14, 2015OAIDrug Quality Assurance2015
Mar 12, 2015NAIDrug Quality Assurance2015
Nov 13, 2014NAIDrug Quality Assurance2015
Feb 21, 2014OAIDrug Quality AssuranceYes2014
Feb 21, 2014VAIBioresearch MonitoringYes2014
Feb 21, 2014OAIUnapproved and Misbranded DrugsYes2014
Feb 21, 2014VAIPostmarket Assurance: DevicesYes2014
Feb 21, 2014OAICompliance: DevicesYes2014
Aug 17, 2012VAIDrug Quality AssuranceYes2012
Aug 17, 2012VAIPostmarket Surv. and EpidemiologyYes2012
Aug 17, 2012VAICompliance: DevicesYes2012
Jun 17, 2011OAIDrug Quality Assurance2011
Jun 17, 2011OAIPostmarket Surv. and Epidemiology2011
May 18, 2010VAIDrug Quality Assurance2010
May 18, 2010NAIBioresearch Monitoring2010

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

Oct 21, 2022Warning Letter · CDER
Oct 11, 2022Warning Letter · CDER
Sep 22, 2020Warning Letter · CDER
Sep 2, 2016Warning Letter · CDER
Sep 24, 2013Warning Letter · CDER
Unclaimed profile

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Methods, equipment, quality scope, capacity, turnaround, and commercial contacts are not available.

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