Novartis Vaccines & Diagnostics, Ltd. - June 11, 2015
Issue Date
Jun 11, 2015
Region
HQ
Category
Drug
$117.00
Contact Name
Laura E. O'Brien
Contact Title
Site Head, Liverpool
Address 1
Renaissance Way
City
Liverpool
Zip/Postal Code
L24 9GR
Country
United Kingdom
Inspection Range
Jun 01, 2015 - Jun 11, 2015
Pages
9
First Observation
The controls over the Fluvirin influenza vaccine manufacturing equipment cleaning, cleaning validation, sanitization processes and maintenance are inadequate.
Investigator(s): Gene Arcy and Omotunde O. Osunsanmi