Bion Enterprises, Ltd. - Nov. 18, 2016
Issue Date
Nov 18, 2016
Region
Central
Category
Device
$117.00
Contact Name
Melinda M. Ascher
Contact Title
Vice President of Operations
Address 1
455 State St.
Address 2
Ste. 100
City
Des Plaines
State
IL
Zip/Postal Code
60016
Country
United States
Inspection Range
Nov 08, 2016 - Nov 18, 2016
Pages
2
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): David J. Gasparovich