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...]