FDA Inspection 790518 — Bloodworks

Bloodworks — FEI 3001617760

The FDA completed an inspection of Bloodworks on July 6, 2012 in Renton, WA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 6, 2012
Fiscal Year
2012
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Renton, WA (United States)

Citations

IDCFRDescription
922521 CFR 606.171Biological product deviation report
9821 CFR 606.100(c)Thorough investigations