1206168

Sri Krishna Pharmaceuticals Limited — FEI 3005280525

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
May 19, 2023
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hyderabad (India)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
202721 CFR 211.192Investigations of discrepancies, failures
2129721 CFR 211.186(a)Master production and control records, procedure
241921 CFR 211.198(a)Complaint Handling Procedure
356521 CFR 211.58Buildings not maintained in good state of repair