FDA Inspection 1115744 — Aultman Hospital

Aultman Hospital — FEI 1570996

The FDA completed an inspection of Aultman Hospital on January 24, 2020 in Canton, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 24, 2020
Fiscal Year
2020
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Canton, OH (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs