Seimens/Pet Net Solutions - May 6, 2009
Issue Date
May 06, 2009
Region
Southeast
Category
Drug
$117.00
Address 1
2310 Presidential Dr.
City
Durham
State
NC
Zip/Postal Code
27703
Country
US
Inspection Range
May 04, 2009 - May 06, 2009
Pages
1
First Observation
Batch 180N02270802, which was utilized in the stability studies failed the membrane filter integrity test (bubble point) on 2/27/08. This failure to meet specifications is not documented in the DMF.
Investigator(s): Eileen J. Bannerman and Frank W. Perrella