Sontec Instruments, Inc. - Oct. 21, 2016
Issue Date
Oct 21, 2016
Region
Southwest
Category
Device
$117.00
Contact Name
Caron M. Scanlan
Contact Title
Executive Vice President
Address 1
7248 S. Tucson Way
City
Centennial
State
CO
Zip/Postal Code
80112
Country
United States
Inspection Range
Oct 17, 2016 - Oct 21, 2016
Pages
4
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Kathleen S. Tormey and Matthew M. Vernon