Investor Presentaiton
Update on ongoing US FDA matters
November
2015
Warning Letter
For Three Sites
Activity
Document Control
December
2015
January 2016
March 2016
May 2016
Response Submitted
First status update
Second status update
Third status update
Electronic data reliability
Infrastructure upgrades
QC systems corrections and simplification
Sterility assurance
Manufacturing procedures
Investigation rigor
Status
Done
Of the
Nearly done
Nearly done
Warning Letter
Commitments,
WIP
Nearly done
94% will be
completed by
June.
WIP
WIP
WARNING
FDA
Observation categories included: documentation
practices and control, laboratory testing
procedures, incident investigation practices, and
standard operating procedures.
Independent product quality
assessments performed by
Lachman Consulting Services.
No questions or
comments by
FDA to date
Investor Presentation - 2016
Dr. Reddy's Laboratories Ltd.
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