Immuno Concepts, N.A., Ltd. - April 9, 2019
Issue Date
Apr 09, 2019
Region
Southwest
Category
Device
$117.00
Contact Name
Eric S. Hoy
Contact Title
Chief Scientific Officer
Address 1
2280 Springlake Rd.
Address 2
Ste. 106
City
Dallas
State
TX
Zip/Postal Code
75234 -5830
Country
United States
Inspection Range
Apr 05, 2019 - Apr 05, 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): Roy Baby