Sirtex Wilmington, LLC. - July 12, 2013
Issue Date
Jul 12, 2013
Region
Northeast
Category
Device
$117.00
Contact Name
Heather Roseanne Winslade
Contact Title
Global Head of Regulatory Affairs & Quality
Address 1
16 Upton Dr.
Address 2
#2-4
City
Wilmington
State
MA
Zip/Postal Code
01887-1041
Country
United States
Inspection Range
Jul 08, 2013 - Jul 12, 2013
Pages
2
First Observation
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
Investigator(s): John A. Sciacchitano