Alere San Diego, Inc. - June 27, 2014
Issue Date
Jun 27, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Michael R. Imrich
Contact Title
GM/VP Operations/Site Leader
Address 1
9975 Summers Ridge Rd.
City
San Diego
State
CA
Zip/Postal Code
92121-2997
Country
United States
Inspection Range
May 05, 2014 - Jun 27, 2014
Pages
9
First Observation
Procedures for design input have not been adequately established.
Investigator(s): Donna L. Tartaglino Besone and Scott K. Zika