Stradis Medical, LLC dba Stradis Healthcare - Aug. 5, 2021
Issue Date
Aug 05, 2021
Region
Southeast
Category
Device
$117.00
Contact Name
Adam H. Sokol
Contact Title
General Manager/President/Co- Owner
Address 1
3025 Northwoods Pkwy.
City
Peachtree Corners
State
GA
Zip/Postal Code
30071-1524
Country
United States
Inspection Range
Jul 19, 2021 - Aug 05, 2021
Pages
21
First Observation
The organizational structure has not been adequately established and maintained to ensure that devices are produced in accordance with 21 CFR 820.
Investigator(s): Dawn M. Braswell and Inga M. Warr