Hospira, Inc. - June 8, 2016
Issue Date
Jun 08, 2016
Region
Southwest
Category
Drug
$117.00
Contact Name
Jonathan J. Rushford
Contact Title
Site Head/Vice President Operations
Address 1
1776 Centennial Dr.
City
McPherson
State
KS
Zip/Postal Code
67460
Country
United States
Inspection Range
May 16, 2016 - Jun 08, 2016
Pages
21
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): Shafiq S. Ahadi, Brett R. Havranek, Carl A. Huffman III, and Michele Perry-Williams