Coloplast Manufacturing US, LLC - April 5, 2010
Issue Date
Apr 05, 2010
Region
Central
Category
Drug
$117.00
Address 1
1940 Commerce Dr.
City
N Mankato
State
MN
Zip/Postal Code
56003
Country
US
Inspection Range
Mar 18, 2010 - Apr 05, 2010
Pages
4
First Observation
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Investigator(s): Melissa I. Michurski