FiberTech RoMack, Leoni Fiber Optics, Inc. - Aug. 10, 2016
Issue Date
Aug 10, 2016
Region
Central
Category
Device
$117.00
Contact Name
Hendrik Coldenstrodt-Ronge
Contact Title
CEO and CFO
Address 1
209 Bulifants Blvd.
City
Williamsburg
State
VA
Zip/Postal Code
23188-5729
Country
United States
Inspection Range
Aug 08, 2016 - Aug 10, 2016
Pages
3
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): Marc S. Neubauer