FDA 483 - Astellas Pharma Inc. - June 02, 2025

Astellas Pharma Inc., a sterile drug product manufacturer in Takaoka, Toyama, Japan, was subject to an FDA inspection from June 2nd to June 6th, 2025. This inspection led to the issuance of an FDA Form 483, documenting several observations of non-compliance with current good manufacturing practices.Key issues included inadequate written procedures for production and process controls. Specifically, the visual inspection process for injection vials was found to be insufficient, lacking supplemental inspections for visible particles. Additionally, the challenge test vials used for qualifying visual inspectors did not adequately represent particles potentially originating from the manufacturing environment.Significant deficiencies were also noted in procedures designed to prevent microbiological contamination. The firm"s disinfectant efficacy study (Protocol # 22Hl-015) was deemed inadequate. This was due to insufficient microorganism inoculation levels, a disinfection method in the study that differed from routine cleaning practices, the omission of critical USP vegetative bacterial challenge organisms (like E. coli, S. aureus, and P. aeruginosa), and the failure to evaluate all surfaces within the aseptic manufacturing area for disinfectant efficacy. Astellas Pharma Inc. is expected to address these observations with comprehensive corrective and preventive actions to ensure product quality and sterility.