Audifon-USA, Inc. - Nov. 27, 2018
Issue Date
Nov 27, 2018
Region
Southeast
Category
Device
$117.00
Contact Name
Monica R. Davis
Contact Title
Production Manager
Address 1
403 Chairman Ct.
Address 2
Ste. 1
City
Debary
State
FL
Zip/Postal Code
32713-4842
Country
United States
Inspection Range
Nov 26, 2018 - Nov 27, 2018
Pages
3
First Observation
Software used as part of the quality system has not been adequately validated for its intended use according to an established protocol.
Investigator(s): Richard K. Vogel