Advanced Accelerator Applications USA, Inc. - Nov. 3, 2022
Nov 03, 2022
Sergio Cerdas Castro
Head of US AAA Technical Operations and Site Head
57 E. Willow St.
Oct 24, 2022 - Nov 03, 2022
Investigator(s): Mindy M. Chou, Robin P. Mathew, and Victoria Spivak
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.