FDA warns Novartis on Austrian generic manufacturing plant cGMP failures

The US Food and Drug Administration has written to Joseph Jimenez, chief executive of Swiss drug major Novartis (NOVN: VX), relating to its investigation of the pharmaceutical manufacturing plant at Ebewe Pharma’s Unterach am Attersee, Austria, production facility, which identified significant violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals. Ebewe was acquired by Novartis’ generics subsidiary Sandoz in 2009.

The FDA said these violations cause the firm’s drug product(s) to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 USC 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, the FDA stated.

In addition, the (b)(4) Injection (b)(4) mg/mL and (b)(4) Injection (b)(4) mg/mL that the company distributed without the required FDA marketing application is an unapproved new drug under section 505(a) of the Act (21 USC section 355(a)).