Carma Laboratories, Inc. - Nov. 27, 2012
Issue Date
Nov 27, 2012
Region
Central
Category
Drug
$117.00
Address 1
5801 W Airways Ave.
City
Franklin
State
WI
Zip/Postal Code
53132-9111
Country
US
Inspection Range
Nov 15, 2012 - Nov 27, 2012
Pages
2
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 variability in the characteristics of in-process material and the drug product.
Investigator(s): Sandra A. Hughes