FDA Inspection 834005 — University of South Alabama Children's and Women's Hospital

University of South Alabama Children's and Women's Hospital — FEI 1000113027

The FDA completed an inspection of University of South Alabama Children's and Women's Hospital on May 31, 2013 in Mobile, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 31, 2013
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Mobile, AL (United States)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
16021 CFR 606.160(a)(1)Person performing, test results, interpretation