FDA EIR - AGC Biologics, Inc. - March 19, 2021

An FDA pre-license inspection of AGC Biologics Inc.'s drug substance manufacturing facility in Bothell, WA, was conducted from March 11-19, 2021. This inspection, carried out under regulatory frameworks including CP 7356.002M, CP 7346.832, and ICH Q7, focused on ensuring the firm's compliance for new drug products. Following the inspection, the company was issued a 16-Item FDA Form 483, indicating significant objectionable conditions. Key violations identified primarily centered on deficiencies in the firm's quality management system, manufacturing operations, and facility/equipment control. Specific issues included manufacturing steps being performed without Quality Unit approval or inclusion in master batch records, inadequate validation and configuration of manufacturing systems, and failure to consistently follow written procedures. The Quality Unit itself was cited for not adhering to out-of-specification procedures, conducting inadequate product impact assessments following nonconformances, and performing insufficient root cause investigations into analytical assay failures. Furthermore, deficiencies were noted in GMP system installation, utility testing and maintenance, and general facility and equipment upkeep, such as unsealed freezers and deteriorated cleanroom sealants. Documentation and logbook management also presented recurrent problems. These findings necessitate comprehensive corrective actions from AGC Biologics Inc. to address the identified regulatory deviations and ensure robust manufacturing and quality control practices.