Ondal Medical Systems of America - June 22, 2015
Issue Date
Jun 22, 2015
Region
Central
Category
Device
$117.00
Contact Name
Ruediger Wisch
Contact Title
Quality and Safety Manager
Address 1
540 Eastpark Ct.
Address 2
Ste. A
City
Sandston
State
VA
Zip/Postal Code
23150-1344
Country
United States
Inspection Range
Jun 18, 2015 - Jun 22, 2015
Pages
2
First Observation
Software used as part of production and the quality system has not been validated for its intended use according to an established protocol.
Investigator(s): Sean R. Moynihan