Sigma-Tau Pharmasource, Inc. - Nov. 7, 2013
Issue Date
Nov 07, 2013
Region
Central
Category
Drug
$117.00
Contact Name
James J. Carmelitano
Contact Title
VP Quality Operations
Address 1
6925 Guion Rd.
City
Indianapolis
State
IN
Zip/Postal Code
46268-2582
Country
United States
Inspection Range
Nov 06, 2013 - Nov 07, 2013
Pages
1
First Observation
Control procedures are not established which monitor the output of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
Investigator(s): Meisha R. Waters