FDA Inspection 940563 — The Hospitals of Providence East Campus

The Hospitals of Providence East Campus — FEI 3007567038

The FDA completed an inspection of The Hospitals of Providence East Campus on August 5, 2015 in El Paso, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 5, 2015
Fiscal Year
2015
Product Type
Biologics
Project Area
Blood and Blood Products
Location
El Paso, TX (United States)

Citations

IDCFRDescription
1220221 CFR 606.170(a)Adverse Reaction - Investigations
908021 CFR 600.12(b)(2)Retention - Records of Recall
908921 CFR 600.14(c)When to report