Sanofi

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to investigate all critical deviations.

Passage 2

Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.

Passage 3

Failure to have equipment of the appropriate design and suitability for their intended use for the manufacture of APIs.

Passage 4

Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP.

Passage 5

Failure to ensure all production deviations are reported and evaluated, and that critical deviations are investigated, and the conclusions are recorded.

Passage 6

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.