Jacobus Pharmaceutical Co., Inc. - February 24, 2011
Issue Date
Feb 24, 2011
Region
Central
Category
Drug
$117.00
Address 1
Industrial Research Building, Schalks Crossing Road
City
Plainsboro
State
NJ
Zip/Postal Code
08536
Country
US
Inspection Range
Jan 24, 2011 - Feb 18, 2011
Pages
6
First Observation
The written stability program for drug products does not include reliable, meaningful, and specific test methods.
Specifically, your stability program for Dapsone 25 mg and 100 mg tablets does not include a stability-indicating method to monitor potential impurities.
Investigator(s): Atul J. AgrawalSpecifically, your stability program for Dapsone 25 mg and 100 mg tablets does not include a stability-indicating method to monitor potential impurities.