FDA Inspection 1042421 — Nassau Health Care Corporation D/B/A/ NuHealth

Nassau Health Care Corporation D/B/A/ NuHealth — FEI 2473605

The FDA completed an inspection of Nassau Health Care Corporation D/B/A/ NuHealth on Feb 22, 2018 in East Meadow, NY. 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)
End Date
Feb 22, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
East Meadow, NY (United States)

Citations

IDCFRDescription
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
907621 CFR 600.12(a)Maintenance - concurrence