Med-Dyne, Inc. - Jan. 30, 2023
Issue Date
Jan 30, 2023
Region
Central
Category
Device
$117.00
Contact Name
Ewart W. Johnson Jr.
Contact Title
President
Address 1
2775 S. Floyd St.
City
Louisville
State
KY
Zip/Postal Code
40209-1817
Inspection Range
Jan 23, 2023 - Jan 30, 2023
Pages
3
First Observation
The written MDR Procedure does not include an internal system which provides for timely and effective identification of events that may be subject to medical device reporting requirements.
Investigator(s): Shannon A. Gregory