Johnson Matthey Pharma Services - January 15, 2010
Issue Date
Jan 15, 2010
Region
Northeast
Category
Drug
$117.00
Address 1
70 Flagship Dr.
City
N Andover
State
MA
Zip/Postal Code
01845-6126
Country
US
Inspection Range
Jan 13, 2010 - Jan 15, 2010
Pages
1
First Observation
The firm failed to perform Performance Qualification (PQ) for their High Pressure Liquid Chromatograph (HPLC) systems. For all Agilent 1100's Series HPLC systems; no performance qualification is performed on the detector, pump, oven and auto injector. In addition, firm failed to monitor the lamp hours and the energy of their lamps after hours of operation as recommended by the manufacturer.
Investigator(s): Paraluman S. Leonin and Kenneth H. Williams