Lupin Limited
3 extracted findings
FDA source excerpt, selected passage
Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of intermediates and API.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of intermediates and API.
Source passage selected by the model
02
Failure to establish written procedures to monitor the progress and control the performance of processing steps that may cause variability in the quality characteristics of your intermediates and API.
Source passage selected by the model
03
Failure to investigate all critical deviations.
Source passage selected by the model