Concord Laboratories, Inc. - July 7, 2009
Issue Date
Jul 07, 2009
Region
Central
Category
Drug
$117.00
Address 1
140 New Dutch Ln.
City
Fairfield
State
NJ
Zip/Postal Code
7004
Country
US
Inspection Range
Jun 16, 2009 - Jul 07, 2009
Pages
3
First Observation
The firm's change control procedure, SOP GN-005, Change Control Authorization Procedure was not followed. For example, the cleaning agent for the punches and dies of the table presses was changed; however, no evaluation was conducted to determine the impact of the change to the cleaning procedures and if cleaning validation was required.
Investigator(s): Douglas C. Kovacs, Helen Verdel, and Barbara J. Wilimczyk-Macri