 Frontida BioPharm, Inc. receives a significant warning letter for cross contamination (08/15/16) during an audit that extended from June 15 through July 17, 2015. The FDA deemed the drug products adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 351(a)(2)(B). The FDA investigators … [Read more...]
WHO, TGA AND MHRA JUSTIFY RELEASE OF RANBAXY’S PRODUCTS — EVEN AFTER FDA ISSUES $500 MILLION FINE
WHAT IS THE MEANING OF “ADULTERATEDâ€? Pharma Evolution just released an "abridged" Blog, "WHO, TGA & MHRA: Just What Does the Word 'Adulterated' Mean?" (see below).() Should you wish to read and comment on this abridged version, please go to the location listed above. To view the total Blog, continue reading … [Read more...]
