NovaLung Gmbh - 11/17/2011
Issue Date
Nov 17, 2011
Region
Central
Category
Device
$117.00
Address 1
Benzstrabe 4-7
City
Oberstenfeld
Zip/Postal Code
D-71720
Country
Germany
Inspection Range
Nov 14, 2011 - Nov 17, 2011
Pages
5
First Observation
The design history file does not demonstrate that the design was developed following the approved design plan and does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Donna L. Tartaglino Besone