747074

Providence Health System Southern California — FEI 2071846

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 27, 2011
Fiscal Year
2011
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Burbank, CA (United States)

Citations

IDCFRDescription
1503021 CFR 606.60(b)Equipment calibration frequency
6121 CFR 606.60(a)Provide proper equipment to meet requirements
7621 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
908921 CFR 600.14(c)When to report
9421 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration