856795

Nassau Health Care Corporation d/b/a/ NuHealth — FEI 2473605

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 25, 2013
Fiscal Year
2014
Product Type
Biologics
Project Area
Blood and Blood Products
Location
East Meadow, NY (United States)

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
15521 CFR 606.160(b)Required records
15921 CFR 606.160(a)(1)Legibility and indelibility
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
16121 CFR 606.160(a)(2)Determination of lot numbers and supplies
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
7721 CFR 606.100(b)Written SOPs available for use by personnel