FDA Warns U.S., Italian Drugmakers About Manufacturing Problems

Drug manufacturing facilities in Wisconsin and Italy are the most recent recipients of FDA warnings over their manufacturing quality.

ChemRite CoPac, a contract manufacturer of liquid, lotion, and paste chemical formulations based in Lannon, Wis., and Tubilux Pharma SpA, a company that specializes in designing and developing ophthalmic drugs in Rome, appear to be producing drugs in facilities with concerns that violate the Federal, Food, Drug, and Cosmetic Act (FDCA), according to warning letters posted online July 18.

Both warning letters summarize violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, which the FDA uses to ...