Ionetix Corp. - June 4, 2021
Issue Date
Jun 04, 2021
Region
Central
Category
Drug
$117.00
Contact Name
Christopher K. Shreves
Contact Title
Regional Director
Address 1
200 Lothrop St.
Address 2
Rm. A332
City
Pittsburgh
State
PA
Zip/Postal Code
15213-2536
Country
United States
Inspection Range
May 26, 2021 - Jun 04, 2021
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): Jazmine N. Still