Tolmar, Inc. - June 18, 2015
Issue Date
Jun 18, 2015
Region
Southwest
Category
Drug
$117.00
Contact Name
Francisco Gutierrez
Contact Title
Vice President of Quality
Address 1
1413 Duff Dr.
City
Fort Collins
State
CO
Zip/Postal Code
80524-2709
Country
United States
Inspection Range
Jun 15, 2015 - Jun 18, 2015
Pages
3
First Observation
Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variablity in the characteristics of in-process material and the drug product.
Investigator(s): Michael A. Charles, Doan T. Nguyen, and Zachary L. Stamm