If an API has an impurity, does the dosage form manufacturer have the responsibility to identify it if the API manufacturer provides a C of A? Which of the two does FDA hold legally responsible? 1.12K viewsOctober 10, 2022DrugsPharmaceutical 0 Sam Smith11.38K January 8, 2021 0 Comments Spread the loveSpread the love 1 Answer ActiveVotedNewestOldest 0 Blogolu28.38K Posted January 8, 2021 0 Comments Spread the loveQ7A does not address dosage form manufacturer responsibilities nor does it address associated legal liabilities. Spread the love Register or Login