Ataia, Inc. - March 7, 2022
Issue Date
Mar 07, 2022
Region
Central
Category
Device
$117.00
Contact Name
Amy L. Foertsch
Contact Title
Chief Operating Officer
Address 1
8070 Georgia Ave.
Address 2
Ste. 410
City
Silver Spring
State
MD
Zip/Postal Code
20910-4981
Country
United States
Inspection Range
Mar 02, 2022 - Mar 07, 2022
Pages
6
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Jude C. Dike and Lindsey L. Kirsh