Century Pharmaceuticals, Inc. - September 10, 2009
Issue Date
Sep 10, 2009
Region
Central
Category
Device
$117.00
Address 1
10377 Hague Rd.
City
Indianapolis
State
IN
Zip/Postal Code
46256-3316
Country
US
Inspection Range
Sep 08, 2009 - Sep 10, 2009
Pages
2
First Observation
Corrective and preventive action procedures addressing implementation and recording of changes in methods and procedures to correct and prevent identified quality problems were not established, documented, and implemented.
Investigator(s): Calvin K. Cook