'Show' and 'Shadow' Heparin Facilities Targeted in Pair of FDA Warning Letters
This article was originally published in The Gold Sheet
FDA issued heparin-related warning letters last month to two Chinese API suppliers - one for posing as a heparin API supplier, and the other for supplying adulterated heparin to the U.S. in violation of cGMP requirements
You may also be interested in...
Fourteen second-quarter warning letters focused on microbial contamination issues as well as mix-ups, missing data, out-of-specification reporting procedures and more
Officials from the US Food and Drug Administration cited their reasons for refusing to review new applications for companies with unresolved data integrity failures.