FDA Inspection 1315714 — Children's Hospital of Orange County

Children's Hospital of Orange County — FEI 2077856

The FDA completed an inspection of Children's Hospital of Orange County on April 29, 2026 in Orange, CA. 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
April 29, 2026
Fiscal Year
2026
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Orange, CA (United States)

Citations

IDCFRDescription
1807221 CFR 630.10(b)Form and manner of educational material
1809321 CFR 630.10(g)(1)Proof Of Identity