Mayo Clinic PET Radiochemistry Facility - Dec. 12, 2019
Issue Date
Dec 12, 2019
Region
Pacific
Category
Drug
$117.00
Contact Name
Joseph C. Hung
Contact Title
Professor of Radiology and Pharmacy and Regulatory Officer
Address 1
5861 E. Mayo Blvd.
City
Phoenix
State
AZ
Zip/Postal Code
85054
Country
United States
Inspection Range
Dec 10, 2019 - Dec 12, 2019
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 and Christopher M. Jenner