Sanofi
6 extracted findings
FDA source excerpt, selected passage
Failure to investigate all critical deviations.
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 investigate all critical deviations.
Source passage selected by the model
02
Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.
Source passage selected by the model
03
Failure to have equipment of the appropriate design and suitability for their intended use for the manufacture of APIs.
Source passage selected by the model
04
Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.
Source passage selected by the model
05
Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated, and the conclusions are recorded.
Source passage selected by the model
06
Failure to address deviations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any deviations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any deviations.
Source passage selected by the model