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Facility profile

Fresenius Medical Care North America

Testing & analysis · Drug product manufacturing · Ogden, UT

FDA recordFDA directory updated Jul 22, 2026Profile not yet claimed6 registered company locations
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.

AnalysisLabelManufacturePackSterilize
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 22, 2026

Latest matched inspection
Official action indicated (OAI)

Mar 6, 2026 · The findings may warrant official FDA action.

Matched compliance actions
Past action on file · 2013

More than five years old · review later records.

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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 history15 inspection records

FDA inspection history

15 records, Jun 2009 – Mar 2026 · 5 NAI · 8 VAI · 2 OAI

DateClassProject areaCitationsFY
Mar 6, 2026OAIDrug Quality AssuranceYes2026
May 21, 2021VAIDrug Quality AssuranceYes2021
Aug 13, 2020VAIDrug Quality Assurance2020
Aug 18, 2017VAIDrug Quality Assurance2017
May 18, 2017NAICompliance: Devices2017
Jan 10, 2014VAIPostmarket Assurance: Devices2014
Jan 10, 2014VAICompliance: Devices2014
Jan 10, 2014VAIDrug Quality Assurance2014
Dec 7, 2012OAICompliance: DevicesYes2013
Dec 7, 2012NAIPostmarket Assurance: DevicesYes2013
Mar 8, 2012VAIDrug Quality Assurance2012
Feb 4, 2011VAIDrug Quality Assurance2011
Sep 9, 2010NAICompliance: Devices2010
Jun 12, 2009NAICompliance: Devices2009
Jun 12, 2009NAIDrug Quality Assurance2009

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

Matched compliance actions

Mar 5, 2013Warning Letter · CDRH
Unclaimed profile

Service details not yet provided

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

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