Klinge Chemicals Limited - June 3, 2010
Issue Date
Jun 03, 2010
Region
HQ
Category
Drug
$117.00
Address 1
1 Bessemer Dr.
Address 2
Kelvin Industrial Estate
City
East Kilbride
State
Gl
Zip/Postal Code
G75 0QX
Country
US
Inspection Range
Jun 01, 2010 - Jun 03, 2010
Pages
4
First Observation
The firm does not have an active stability monitoring program for the US marketed API, For the past three years, the firm has not placed an annual batch on stability and there is no routine testing conducted at designated test stations. Since 2008m, the firm has released batches of API to the US for distribution.
Investigator(s): S. Atts and Jose A. Lopez Rubet