Macromedics BV - Aug. 9, 2018
Issue Date
Aug 09, 2018
Region
HQ
Category
Device
$117.00
Contact Name
Leo G. De Mooy
Contact Title
Chief Executive Officer
Address 1
Kouwe Hoek 18
City
Waddinxveen, Zuid-Holland
Zip/Postal Code
2741 PX
Country
Netherlands
Inspection Range
Aug 06, 2018 - Aug 09, 2018
Pages
7
First Observation
The design history file does not demonstrate that the design was developed following the requirements of 21 CFR 820.
Investigator(s): Christine I. Shaw