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Facility profile

Fenwal International, Inc.

Testing & analysis · Drug product manufacturing · Maricao, PR

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed3 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 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

Feb 5, 2026 · FDA documented observations for voluntary correction.

Matched compliance actions
Warning Letter · Sep 2023

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 history22 inspection records

FDA inspection history

22 records, Feb 2009 – Feb 2026 · 7 NAI · 8 VAI · 7 OAI

DateClassProject areaCitationsFY
Feb 5, 2026VAIBlood and Blood ProductsYes2026
Sep 18, 2024VAIBlood and Blood ProductsYes2024
Sep 24, 2022OAIBlood and Blood ProductsYes2022
Sep 24, 2022NAIVaccines and Allergenic ProductsYes2022
Sep 24, 2021OAIDrug Quality AssuranceYes2021
Sep 24, 2021OAIBlood and Blood ProductsYes2021
Sep 26, 2019OAIBlood and Blood ProductsYes2019
Aug 22, 2017NAICompliance: DevicesYes2017
Aug 22, 2017VAIDrug Quality AssuranceYes2017
Mar 25, 2015VAIDrug Quality AssuranceYes2015
Mar 25, 2015NAICompliance: DevicesYes2015
Feb 21, 2014NAIDrug Quality Assurance2014
Feb 21, 2014NAICompliance: Devices2014
Apr 25, 2013OAIDrug Quality AssuranceYes2013
Apr 25, 2013OAICompliance: DevicesYes2013
Feb 24, 2012VAIDrug Quality AssuranceYes2012
Feb 24, 2012VAICompliance: DevicesYes2012
Mar 23, 2010VAICompliance: DevicesYes2010
Mar 23, 2010VAIDrug Quality AssuranceYes2010
Feb 2, 2009OAIDrug Quality Assurance2009
Feb 2, 2009NAIPostmarket Assurance: Devices2009
Feb 2, 2009NAICompliance: Devices2009

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

Matched compliance actions

Sep 14, 2023Warning Letter · CBER
May 15, 2020Warning Letter · CBER
Aug 16, 2013Warning Letter · CBER
Jun 1, 2012Warning Letter · CBER
Unclaimed profile

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

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