Dynarex Corp. - March 2, 2017
Issue Date
Mar 02, 2017
Region
Northeast
Category
Device
$117.00
Contact Name
Marc Somelofski
Contact Title
Director, Regulatory Affairs and Quality Assurance
Address 1
10 Glenshaw St.
City
Orangeburg
State
NY
Zip/Postal Code
10962
Country
United States
Inspection Range
Feb 17, 2017 - Mar 02, 2017
Pages
2
First Observation
The results of design validation, including method(s), were not adequately documented in the design history file.
Investigator(s): Kwong Lee