Alere San Diego, Inc. - Jan. 11, 2019
Issue Date
Jan 11, 2019
Region
Pacific
Category
Device
$117.00
Contact Name
Todd E. Thessen
Contact Title
Site Director, Operations
Address 1
9975 Summers Ridge Rd.
City
San Diego
State
CA
Zip/Postal Code
92121-2997
Country
United States
Inspection Range
Jan 07, 2019 - Jan 11, 2019
Pages
4
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): James A. Lane and Juanj N. Wu