Bright Enterprises, Inc. - June 18, 2018
Issue Date
Jun 18, 2018
Region
Southeast
Category
Device
$117.00
Contact Name
Lee Kirk Sparks
Contact Title
President
Address 1
4833 W. Gate City Blvd.
City
Greensboro
State
NC
Zip/Postal Code
27407-5305
Country
United States
Inspection Range
Jun 12, 2018 - Jun 18, 2018
Pages
2
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): Christopher B. May