Vygon Gmbh & Co. KG - June 9, 2016
Issue Date
Jun 09, 2016
Region
HQ
Category
Device
$117.00
Contact Name
Heinz Loevenich
Contact Title
Direct of Quality Management and Regulatory Affairs
Address 1
Prager Ring 100
City
Aachen
State
North Rhine- Westphalia
Zip/Postal Code
52070
Country
Germany
Inspection Range
Jun 06, 2016 - Jun 09, 2016
Pages
3
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Akbar J. Zaidi