API, Inc. - July 15, 2011
Issue Date
Jul 15, 2011
Region
Central
Category
Drug
$117.00
Address 1
10 Industrial Rd.
City
Fairfield
State
NJ
Zip/Postal Code
07004
Country
US
Inspection Range
Jul 11, 2011 - Jul 15, 2011
Pages
1
First Observation
Changes to batch records regarding the amounts of materials charged for use during production are not documented by the change control process.
Investigator(s): Michael R. Klapal