Breg, Inc. - Feb. 2, 2015
Issue Date
Feb 02, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Carol L. Emerson
Contact Title
Vice President of QA/RA
Address 1
2885 Loker Ave. E
City
Carlsbad
State
CA
Zip/Postal Code
92010-6626
Country
United States
Inspection Range
Jan 29, 2015 - Feb 02, 2015
Pages
2
First Observation
The written MDR procedure does not include an internal system which provides for the timely and effective evalualtion of events that may be subject to medical device reporting requirements.
Investigator(s): Stephen R. Souza