Hamamatsu/Queen's PET Imaging Center, LLC - May 14, 2015
Issue Date
May 14, 2015
Region
Pacific
Category
Drug
$117.00
Contact Name
Garan K. Ito
Contact Title
Director, Diagnostic and lnterventional Se1vices
Address 1
1301 Punchbowl St.
City
Honolulu
State
HI
Zip/Postal Code
96813
Country
United States
Inspection Range
May 12, 2015 - May 14, 2015
Pages
3
First Observation
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
Investigator(s): Lance M. De Souza