US FDA finds cGMP violations at Hospira's Italian facility

On April 1, US injectable drugs and infusion technologies and biosimilars developer Hospira (NYSE: HSP) received a warning letter from the US Food and Drug Administration related to an inspection of the company’s pharmaceutical manufacturing facility located in Liscate, Italy.

The inspection occurred May 5-9 and 12-13, 2014, during which FDA investigators identified significant violations of current Good Manufacturing Practice (cGMP) regulations for finished pharmaceuticals.

According to the warning letter to Hospira’s chief executive Michael Ball, “these violations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 351(a)(2)(B), in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, cGMP.”