US FDA warns Lilly on insulin API manufacturing violations and Roche and Abbott over HIV combo drug concerns

The US Food and Drug Administration issued two lots of warning letters to pharmaceutical majors yesterday, one relating to manufacturing problems at Eli Lilly's Puerto Rico facility where its Humalog insulin is made, and the other to Switzerland's Novartis and Abbott Laboratories of the USA regarding cardiac side effects when their HIV/AIDS drugs are used in combination.

The FDA stated in a web site posting yesterday, confirming a February 5 letter to Lilly's chief executive John Lechleiter, that an inspection of Lilly's production plant located at Carretera, Puerto Rico, identified a significant deviation from the current Good Manufacturing Practice requirements for the manufacture of active pharmaceutical ingredients. 'This deviation causes your API, Lyspro Insulin zinc crystals, 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,' the agency declared.

The FDA said Lilly "failed to adequately investigate critical deviations or a failure of a batch to meet its specifications or quality standards." and has asked the company to evaluate the impact of problems at the plant on its Humalog insulin product.