Aerobiotix, Inc. - Nov. 14, 2018
Issue Date
Nov 04, 2018
Region
Central
Category
Device
$117.00
Contact Name
David L. Kirschman
Contact Title
President & CEO
Address 1
350 Fame Rd.
City
West Carrollton
State
OH
Zip/Postal Code
45449-2313
Country
United States
Inspection Range
Nov 13, 2018 - Nov 14, 2018
Pages
4
First Observation
The design history file does not demonstrate that the design was developed following the approved
design plan and does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Teresa K. Kastner