892551

VA Boston Healthcare System — FEI 1270497

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 8, 2014
Fiscal Year
2014
Product Type
Biologics
Project Area
Blood and Blood Products
Location
West Roxbury, MA (United States)

Citations

IDCFRDescription
16021 CFR 606.160(a)(1)Person performing, test results, interpretation
16121 CFR 606.160(a)(2)Determination of lot numbers and supplies
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
6721 CFR 606.65(e)Following manufacturer's instructions