Hamamatsu/Queens PET Imaging Center, LLC - Dec. 13, 2018
Issue Date
Dec 13, 2018
Region
Pacific
Category
Drug
$117.00
Contact Name
Darlena D. Chadwick
Contact Title
Vice President Patient Care
Address 1
1301 Punchbowl St.
City
Honolulu
State
HI
Zip/Postal Code
96813-2402
Country
United States
Inspection Range
Dec 11, 2018 - Dec 13, 2018
Pages
4
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): Zachary A. Bogorad, Kenneth O. Gee, and Nicholas L. Hunt