University of Wisconsin - Aug. 18, 2010
Issue Date
Aug 18, 2010
Region
Central
Category
Drug
$117.00
Address 1
PET Imaging Center
Address 2
1111 Highland Ave.
City
Madison
State
WI
Zip/Postal Code
53705
Country
US
Inspection Range
Aug 11, 2010 - Aug 18, 2010
Pages
2
First Observation
Regarding manufacture of PET drug 13N NH3, a USP monograph drug which is used for diagnostic purposes and not under IND or RDRC review: No formal process validation or verification (min. three consecutive batches) has been performed.
Investigator(s): Charles R. Cote