DICOM Grid, Inc. dba Ambra Health - July 27, 2022
Issue Date
Jul 27, 2022
Region
Northeast
Category
Device
$117.00
Contact Name
Jillian M. Baxter
Contact Title
Senior Director
Address 1
450 Park Ave South
City
New York
State
NY
Zip/Postal Code
10016
Inspection Range
Jul 19, 2022 - Jul 27, 2022
Pages
6
First Observation
A justification for not reporting the correction or removal action to FDA that included conclusions and reviews by a designated person was not included in the record.
Investigator(s): Colin E. Tack