Boehringer Laboratories, Inc. - November 7, 2011
Issue Date
Nov 07, 2011
Region
Central
Category
Device
$117.00
Address 1
300 Thoms Dr.
City
Phoenixville
State
PA
Zip/Postal Code
19401-5149
Country
US
Inspection Range
Oct 24, 2011 - Nov 07, 2011
Pages
5
First Observation
Design validation did not ensure the device conforms to defined user needs and intended uses.
Investigator(s): Michael J. Nerz