Respiratory Technologies, Inc. - Oct. 9, 2014
Issue Date
Oct 09, 2014
Region
Central
Category
Device
$117.00
Contact Name
Robert W. Clapp
Contact Title
Vice President R&D, Manufacturing and Quality
Address 1
2896 Centre Pointe Dr.
City
Saint Paul
State
MN
Zip/Postal Code
55113-1134
Country
United States
Inspection Range
Oct 07, 2014 - Oct 09, 2014
Pages
2
First Observation
The device history record does not demonstrate that the device was manufactured in accordance with 21 CFR 820.
Investigator(s): Jennifer S. Ness and Marissa S. Steinhagen