Northland Nuclear Medicine, LLC - June 7, 2019
Issue Date
Jun 07, 2019
Region
Central
Category
Drug
$117.00
Contact Name
Nathan J. Fleck
Contact Title
Owner
Address 1
1815 Michigan Ave.
City
Bismarck
State
ND
Zip/Postal Code
58504 - 6121
Country
United States
Inspection Range
Jun 03, 2019 - Jun 07, 2019
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): Scott A. Golladay and Anthony J. Ladner