Lung Assist Maker Warned on Lacking Documentation

May 4, 2012
Lax documentation of testing failures and inadequate design history files for Novalung’s surgical Lung Assist device have earned the German company an FDA warning letter. The enforcement action follows a four-day investigation of the devicemaker’s Oberstenfeld, Germany, plant in November and inadequate follow-up responses, the April 2 letter states.
Devices & Diagnostics Letter