BioMedical Enterprises, Inc. - March 22, 2012
Issue Date
Mar 22, 2012
Region
Southwest
Category
Device
$117.00
Address 1
14785 Omicron Dr.
Address 2
Ste. 205
City
San Antonio
State
TX
Zip/Postal Code
78245-3223
Country
US
Inspection Range
Mar 16, 2012 - Mar 22, 2012
Pages
3
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): Jeffrey R. Wooley