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1273929

Sri Krishna Pharmaceuticals Limited — FEI 3005280525

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
June 27, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Hyderabad (India)

Facility

Other inspections at this facility

  • 1206168 (OAI Fri May 19 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913677 (OAI Thu Dec 04 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 757337 (VAI Wed Nov 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
185121 CFR 211.84(e)Rejecting When Specifications Not Met
187921 CFR 211.180(c)Records not made readily available to FDA
202721 CFR 211.192Investigations of discrepancies, failures
202821 CFR 211.192Extent of discrepancy, failure investigations
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
435121 CFR 211.160(b)(3)Drug products - samples representative, identified properly