Kremers Urban Pharmaceuticals, Inc. - Nov. 2, 2012
Issue Date
Nov 02, 2012
Region
Central
Category
Drug
$117.00
Address 1
1101 C Ave. W
City
Seymour
State
IN
Zip/Postal Code
47274-3342
Country
US
Inspection Range
Oct 15, 2012 - Oct 31, 2012
Pages
5
First Observation
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
Investigator(s): Larry K. Austin and Jeffrey D. Meng