Axiobionics, LLC - May 15, 2014
Issue Date
May 15, 2014
Region
Central
Category
Device
$117.00
Contact Name
Philip E. Muccio
Contact Title
President
Address 1
6111 Jackson Rd.
Address 2
Suite 200
City
Ann Arbor
State
MI
Zip/Postal Code
48103-9167
Country
United States
Inspection Range
May 01, 2014 - May 15, 2014
Pages
3
First Observation
The design history file was not established and does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Amy S. Graf and Tracey L. Siebesma