University of Iowa Pharmaceuticals - Dec. 13, 2013
Issue Date
Dec 13, 2013
Region
Southwest
Category
Drug
$117.00
Contact Name
Mickey L. Wells, Ph.D.
Contact Title
Director of University of Iowa Pharmaceuticals (UIP)
Address 1
115 S Grand Ave.
Address 2
Ste G18, College of Pharmacy
City
Iowa City
State
IA
Zip/Postal Code
52242-1112
Country
United States
Inspection Range
Dec 02, 2013 - Dec 13, 2013
Pages
5
First Observation
Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications 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): John A. Iwen and Michele L. Obert