Tolmar, Inc. - December 11, 2009
Issue Date
Dec 11, 2009
Region
Southwest
Category
Drug
$117.00
Address 1
701 Centre Ave.
City
Fort Collins
State
CO
Zip/Postal Code
80526-1843
Country
US
Inspection Range
Nov 30, 2009 - Dec 11, 2009
Pages
3
First Observation
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.
Investigator(s): Theressa B. Smith, Patricia D. Stahnke, and Ginger M. Sykes