St. Jude Medical - Sept. 14, 2012
Issue Date
Sep 14, 2012
Region
Southwest
Category
Device
$117.00
Address 1
6901 Preston Rd.
City
Plano
State
TX
Zip/Postal Code
75024-2508
Country
US
Inspection Range
Sep 04, 2012 - Sep 14, 2012
Pages
2
First Observation
Document control procedures have not been adequately established and maintained.
Investigator(s): Hamed Ghods, Kimberly Lewandowski-Walker, Iris C. Macinnes, and Jeffrey R. Wooley