Abbott Laboratories - Aug. 11, 2015
Issue Date
Aug 11, 2015
Region
Central
Category
Device
$117.00
Contact Name
Thomas A. Reardon
Contact Title
Site Director
Address 1
100 Abbott Park Rd.
City
Abbott Park
State
IL
Zip/Postal Code
60064
Country
United States
Inspection Range
Aug 04, 2015 - Aug 11, 2015
Pages
2
First Observation
The reporting of the status of the corrective action (CA) for numerous PRISM HCV Masterlot and bulk conjugate failures described in Exceptions Reports (ERs): ERs 327936, 344931, 357007, and 358551, was not conducted in a timely manner.
Investigator(s): Prabhu P. Raju and Susan A. Zullo