Bloodworks – FDA Inspection, Sep 7, 2011

Record Details

This FDA Inspection record concerns Bloodworks, with an inspection on September 7, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Bloodworks
Inspection Date: September 7, 2011
Product Type: Biologics
Office: Center for Biologics Evaluation and Research

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ID · 0c6f0656-a53c-4faf-8318-d9af436a8cb4

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 745191
FDA center: Biologics
Project area: Blood and Blood Products

FDA Citations

21 CFR 606.60(a)Equipment observed, standardized, calibrated
21 CFR 640.3(b)(6)Qualifications of donor - disease transmissible by blood
21 CFR 606.100(c)Thorough investigations
21 CFR 606.160(d)Retention period
21 CFR 211.68(b)input/output verification
21 CFR 211.22(d)Procedures not in writing, fully followed
21 CFR 606.100(b)(12)Criteria for suitability of reissue of returned blood
21 CFR 606.100(b)(2)Donor qualifying tests & measurements

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Other FDA inspections of Bloodworks

Date	Classification	Office	Project area
December 11, 2025	Not classified	Seattle District Office	Blood and Blood Products
May 3, 2024	NAI	Center for Biologics Evaluation and Research	Blood and Blood Products
July 16, 2021	VAI	Center for Biologics Evaluation and Research	Human Cellular, Tissue, and Gene Therapies
April 18, 2019	VAI	Center for Biologics Evaluation and Research	Human Cellular, Tissue, and Gene Therapies
June 7, 2018	NAI	Center for Drug Evaluation and Research	Bioresearch Monitoring