Cenova Receives Warning Letter

Mjolby, Sweden-based device manufacturer Cenova has received a warning letter from the FDA regarding its CoreTherm system. Inspecting Cenova’s facility Sept. 13-15, 2010, the FDA found that “the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation.” In addition, Cenova’s Sept. 20, 2010 response to the inspection “is inadequate” and Cenova “should take prompt action,” the FDA says.