Medtronic Puerto Rico Operations Co. - April 28, 2016
Issue Date
Apr 28, 2016
Region
Southeast
Category
Device
$117.00
Contact Name
Felix M. Negron
Contact Title
Vice President of Operations
Address 1
50 Road 31 km 24.4 Ceiba Norte Industrial Park
City
Juncos
State
PR
Zip/Postal Code
00777
Country
United States
Inspection Range
Apr 05, 2016 - Apr 28, 2016
Pages
6
First Observation
Procedures for monitoring and control of process parameters for a validated process have not been adquately established.
Investigator(s): Laiza V. Garcia