Medtronic Puerto Rico Operations Co. - May 14, 2010
Issue Date
May 14, 2010
Region
Southeast
Category
Device
$117.00
Address 1
Carr #149
Address 2
Km 56.3
City
Villalba
Zip/Postal Code
00766
Country
PR
Inspection Range
Apr 26, 2010 - May 14, 2010
Pages
8
First Observation
The written MDR Procedure does not include an internal system which provides for the timely and effective identification and evaluation of events that may be subject to medical device reporting requirements.
Investigator(s): Laiza V. Garcia and Noreen Muniz