Blue Sky Bio LLC - April 27, 2018
Issue Date
Apr 27, 2018
Region
Central
Category
Device
$117.00
Contact Name
Michele H. Kupcso
Contact Title
Management Representative/Vice President (Accumedix, lnc.)
Address 1
888 E. Belvidere Rd.
Address 2
Ste. 212
City
Grayslake
State
IL
Zip/Postal Code
60030-2571
Country
United States
Inspection Range
Apr 23, 2018 - Apr 27, 2018
Pages
2
First Observation
Procedures for design change have not been adequately established.
Investigator(s): Stephen D. Eich and Nicholas Z. Lu