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Facility profile

Hikma Pharmaceuticals USA Inc.

Testing & analysis · Drug product manufacturing · Columbus, OH

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed
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Listed operations

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

AnalysisLabelManufacturePackParticle Size Reduction
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
No action indicated (NAI)

Apr 30, 2026 · No conditions warranted FDA action in this inspection.

Matched compliance actions
Past action on file · 2009

More than five years old · review later records.

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Shows

Registration status and a latest matched no 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 history29 inspection records

FDA inspection history

29 records, May 2009 – Apr 2026 · 25 NAI · 4 VAI · 0 OAI

DateClassProject areaCitationsFY
Apr 30, 2026NAIDrug Quality Assurance2026
Jan 17, 2025NAIBioresearch Monitoring2025
Jul 23, 2024NAICompliance: Devices2024
Sep 15, 2022NAIDrug Quality Assurance2022
Nov 22, 2019NAIDrug Quality Assurance2020
Apr 16, 2019NAIDrug Quality Assurance2019
Apr 18, 2018VAIDrug Quality AssuranceYes2018
Sep 19, 2017NAIDrug Quality Assurance2017
Aug 29, 2017NAIDrug Quality Assurance2017
May 18, 2017NAIDrug Quality Assurance2017
Apr 14, 2017NAIDrug Quality Assurance2017
Oct 21, 2016VAICompliance: Devices2017
Jul 28, 2016NAIDrug Quality Assurance2016
Jul 28, 2016NAIBioresearch Monitoring2016
Jul 28, 2016NAIBioresearch Monitoring2016
Aug 14, 2015NAIDrug Quality Assurance2015
Jun 26, 2015NAIDrug Quality Assurance2015
Jun 26, 2014VAIBioresearch MonitoringYes2014
May 21, 2014NAIDrug Quality Assurance2014
Dec 20, 2013NAIDrug Quality Assurance2014
Apr 24, 2013NAIBioresearch Monitoring2013
Nov 30, 2012NAIDrug Quality Assurance2013
Oct 11, 2012NAIDrug Quality Assurance2013
Jun 29, 2012NAIDrug Quality Assurance2012
Mar 7, 2012NAIDrug Quality Assurance2012
Oct 21, 2011NAIDrug Quality Assurance2012
Jan 20, 2011VAIDrug Quality AssuranceYes2011
Feb 24, 2010NAIDrug Quality Assurance2010
May 6, 2009NAIDrug Quality Assurance2009

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

Matched compliance actions

Mar 30, 2009Warning Letter · CDER
Mar 30, 2009Warning Letter · CDER
Unclaimed profile

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