The QMN Weekly Bulletin

Procedural Shortcomings at Novalung Plant Prompt Warning Letter

June 8, 2012
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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 said.
The GMP Letter