895756

Zydus Lifesciences Limited — FEI 3002984011

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 5, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Taluka Sanand, Ahmedabad (India)

Citations

IDCFRDescription
202821 CFR 211.192Extent of discrepancy, failure investigations
241921 CFR 211.198(a)Complaint Handling Procedure
438221 CFR 211.198(b)(2)Written record of complaint to include findings, follow-up
890621 CFR 314.81(b)(1)(i)Mix-up