Cardinal Health 414, Inc. - Feb. 25, 2020
Issue Date
Feb 25, 2020
Region
Pacific
Category
Drug
$117.00
Contact Name
Steve R. Morcos
Contact Title
Director of Nuclear Manufacturing
Address 1
5030 1st Ave. S.
Address 2
Ste. 110
City
Seattle
State
WA
Zip/Postal Code
98134-2438
Country
United States
Inspection Range
Feb 18, 2020 - Feb 25, 2020
Pages
5
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): Kenneth O. Gee and Anita Narula