Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes.
Passage 2Failure to validate and verify the suitability of analytical methods.
Passage 3Failure to design a documented, ongoing stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates.
Passage 4Failure to demonstrate that water used in the manufacture of your API is suitable for its intended use.