963109

Dignity Health - Northridge Hospital Medical Center — FEI 2074359

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 11, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Northridge, CA (United States)

Citations

IDCFRDescription
115921 CFR 211.28(a)Clothing appropriate for duties performed
143021 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
143321 CFR 211.42(c)(10)(iii)Air Supply
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
145121 CFR 211.113(b)Procedures for sterile drug products
191421 CFR 211.166(a)Lack of written stability program
202721 CFR 211.192Investigations of discrepancies, failures
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation