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Bloodworks

Drug product manufacturing · Seattle, WA

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

Manufacture
Due diligence

Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
Voluntary action indicated (VAI)

May 3, 2024 · FDA documented observations for voluntary correction.

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 voluntary action indicated inspection.

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Method and source details
View full inspection and compliance history22 inspection records

FDA inspection history

22 records, Mar 2009 – May 2024 · 9 NAI · 12 VAI · 1 OAI

DateClassProject areaCitationsFY
May 3, 2024NAIBlood and Blood ProductsYes2024
May 3, 2024VAIHuman Cellular, Tissue, and Gene TherapiesYes2024
Jul 16, 2021VAIBlood and Blood ProductsYes2021
Jul 16, 2021NAIVaccines and Allergenic ProductsYes2021
Jul 16, 2021VAIHuman Cellular, Tissue, and Gene TherapiesYes2021
Apr 18, 2019VAIHuman Cellular, Tissue, and Gene Therapies—2019
Jun 7, 2018NAIBioresearch Monitoring—2018
May 4, 2018NAIBioresearch Monitoring—2018
Sep 1, 2017NAIHuman Cellular, Tissue, and Gene Therapies—2017
Sep 1, 2017NAIBlood and Blood Products—2017
Aug 17, 2017VAIHuman Cellular, Tissue, and Gene Therapies—2017
Jan 22, 2015VAIBlood and Blood ProductsYes2015
Nov 15, 2013VAIBlood and Blood ProductsYes2014
Mar 19, 2013NAIBlood and Blood Products—2013
Feb 15, 2013VAIPostmarket Assurance: Devices—2013
Feb 15, 2013VAICompliance: Devices—2013
Feb 15, 2013OAIBlood and Blood Products—2013
Sep 7, 2011VAIBlood and Blood ProductsYes2011
Sep 22, 2010VAIBlood and Blood ProductsYes2010
Sep 22, 2010NAIHuman Cellular, Tissue, and Gene TherapiesYes2010
Aug 10, 2009NAIBlood and Blood Products—2009
Mar 27, 2009VAIBlood and Blood ProductsYes2009

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

Matched compliance actions

Apr 16, 2013Warning Letter · CBER
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