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Facility profile

Exela Pharma Sciences, LLC.

Testing & analysis · Drug product manufacturing · Lenoir, NC

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.

AnalysisActive pharmaceutical ingredient (API) manufactureLabelManufacturePackSterilize
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
Official action indicated (OAI)

Nov 15, 2024 · The findings may warrant official FDA action.

Matched compliance actions
Warning Letter · Jul 2025

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

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Shows

Registration status and a latest matched official action indicated inspection.

Doesn’t show

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

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Review the underlying findings, response, and subsequent follow-up before qualification.

Method and source details
View full inspection and compliance history12 inspection records

FDA inspection history

12 records, Dec 2010 – Nov 2024 · 6 NAI · 5 VAI · 1 OAI

DateClassProject areaCitationsFY
Nov 15, 2024OAIDrug Quality Assurance2025
Jul 18, 2019VAIDrug Quality AssuranceYes2019
Dec 19, 2018NAIDrug Quality Assurance2019
Sep 11, 2018NAIBioresearch Monitoring2018
Sep 28, 2017VAIDrug Quality AssuranceYes2017
Jun 8, 2016NAIDrug Quality Assurance2016
Nov 21, 2014VAIDrug Quality Assurance2015
Aug 28, 2014NAIDrug Quality Assurance2014
Apr 12, 2013NAIDrug Quality Assurance2013
Jan 20, 2012NAIDrug Quality Assurance2012
Sep 2, 2011VAIDrug Quality Assurance2011
Dec 10, 2010VAIDrug Quality Assurance2011

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

Matched compliance actions

Jul 2, 2025Warning Letter · CDER
Jul 2, 2025Warning Letter · CDER
Apr 9, 2021Warning Letter · CDER
Unclaimed profile

Service details not yet provided

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

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