Theragen, Inc. - May 23, 2019
Issue Date
May 23, 2019
Region
Central
Category
Device
$117.00
Contact Name
Richard H. Pearce
Contact Title
Vice President of R & D
Address 1
11220 Assett Loop
Address 2
Ste. 101
City
Manassas
State
VA
Zip/Postal Code
20109-7914
Country
United States
Inspection Range
May 20, 2019 - May 23, 2019
Pages
4
First Observation
The written MDR Procedure does not include an internal system which provides for the timely and
effective identification, communication and evaluation of events that may be subject to medical device reporting requirements.
Investigator(s): Tiki J. Dixon