New Standard Device, Inc. - Aug. 8, 2021
Issue Date
Aug 20, 2021
Region
Southwest
Category
Clinical
$117.00
Contact Name
Bob Wigginton
Contact Title
COO/CTP
Address 1
4848 Research Dr.
City
San Antonio
State
TX
Zip/Postal Code
78240
Country
United States
Inspection Range
Aug 16, 2021 - Aug 20, 2021
Pages
4
First Observation
An MDR (medical device report) report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Jennifer Cunningham