FDA Inspection 1070312 — Providence VA Healthcare System

Providence VA Healthcare System — FEI 1273951

The FDA completed an inspection of Providence VA Healthcare System on Oct 30, 2018 in Providence, RI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Oct 30, 2018
Fiscal Year
2019
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Providence, RI (United States)

Citations

IDCFRDescription
15521 CFR 606.160(b)Required records
7821 CFR 606.100(c)Record review prior to release
922521 CFR 606.171Biological product deviation report