817330

Strides Pharma, Inc. — FEI 2434223

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 19, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chestnut Ridge, NY (United States)

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
358521 CFR 211.110(a)Control procedures to monitor and validate performance
438921 CFR 211.198(a)Procedures to be written and followed