Sotera Wireless, Inc. - March 6, 2019
Issue Date
Mar 06, 2019
Region
Pacific
Category
Device
$117.00
Contact Name
Leo M. Lopez
Contact Title
Acting CEO/VP of Operations
Address 1
10020 Huennekens St.
City
San Diego
State
CA
Zip/Postal Code
92121
Country
United States
Inspection Range
Mar 04, 2019 - Mar 06, 2019
Pages
1
First Observation
A justification for not reporting the correction or removal action to FDA that included conclusions, follow-ups, and reviews by a designated person was not included in the record.
Investigator(s): Daniel J. Lahar