AMS Diagnostics, LLC - Jan. 21, 2020
Issue Date
Jan 21, 2020
Region
Southeast
Category
Device
$117.00
Contact Name
Samuel A. Burgos
Contact Title
Director of Operations
Address 1
1790 N. Commerce Pkwy.
City
Weston
State
FL
Zip/Postal Code
33326-3204
Country
United States
Inspection Range
Jan 13, 2020 - Jan 21, 2020
Pages
5
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): Dianiris C. Ayala