St. Jude Medical Puerto Rico, LLC - May 7, 2012
Issue Date
May 07, 2013
Region
Southeast
Category
Device
$117.00
Address 1
Lot A Interior - Carr #2 Km 67.5
Address 2
Santana Indl. Park, Sector Los Pinos
City
Arecibo
Zip/Postal Code
00613-6025
Country
PR
Inspection Range
Apr 23, 2013 - May 07, 2013
Pages
3
First Observation
The appropriate design, construction, placement and installation of manufacturing equipment have not been ensured and equipment used in the manufacturing process does not meet specified requirements.
Investigator(s): Adaliz Santaliz-Cruz