Mayo Clinic PET Radiochemistry Facility - May 11, 2017
Issue Date
May 11, 2017
Region
Southwest
Category
Drug
$117.00
Contact Name
Joseph C. Hung
Contact Title
Director of Radiopharmaceutical Operations
Address 1
5661 E. Mayo Blvd.
City
Phoenix
State
AZ
Zip/Postal Code
85054-4503
Country
United States
Inspection Range
May 04, 2017 - May 11, 2017
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): Stephanie A. Slater