Wavelight GmbH - Sept. 11, 2015
Issue Date
Sep 11, 2015
Region
HQ
Category
Device
$117.00
Contact Name
Martin Reichelt
Contact Title
General Manager
Address 1
Doellnitz 5
City
Pressath
Zip/Postal Code
92690
Country
Germany
Inspection Range
Sep 07, 2015 - Sep 11, 2015
Pages
1
First Observation
A justification for not reporting the correction or removal action to FDA that included conclusions by a designated person was not included in the record.
Investigator(s): Shafiq S. Ahadi