Procedural Shortcomings at Novalung Plant Prompt Warning Letter

Lax documentation of testing failures and inadequate design history files for Novalung’s surgical Lung Assist device has resulted in an FDA warning letter for the German company. 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. A majority of effectiveness checks reviewed by investigators lacked documentation to demonstrate the adequacy of those checks, the FDA says. An employee told agency investigators that all failures are considered corrective and preventive actions, the agency notes.
The GMP Letter