Alere San Diego, Inc. - June 5, 2015
Issue Date
Jun 05, 2015
Region
Pacific
Category
Device
$117.00
Contact Name
Michael R. Imrich
Contact Title
Vice President, Operations and Site Leader
Address 1
9975 Summers Ridge Rd.
City
San Diego
State
CA
Zip/Postal Code
92121
Country
United States
Inspection Range
Apr 13, 2015 - Jun 05, 2015
Pages
7
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Scott K. Zika