Advanced Accelerator Applications USA, Inc. - Nov. 3, 2022
Issue Date
Nov 03, 2022
Region
Central
Category
Drug
$117.00
Contact Name
Sergio Cerdas Castro
Contact Title
Head of US AAA Technical Operations and Site Head
Address 1
57 E. Willow St.
City
Millburn
State
NJ
Zip/Postal Code
07041-1416
Inspection Range
Oct 24, 2022 - Nov 03, 2022
Pages
6
First Observation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.