Camurus Ab - June 3, 2016
Issue Date
Jun 03, 2016
Region
HQ
Category
Device
$117.00
Contact Name
Markus Johnsson
Contact Title
Vice President
Address 1
Forskningsbyn Ideon
Address 2
Ideon Science Park
City
Lund
State
Skane Lan
Zip/Postal Code
223 70
Country
Sweden
Inspection Range
May 30, 2016 - Jun 03, 2016
Pages
2
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Akbar J. Zaidi