FDA 483 - Daizo Corporation - November 06, 2023

Daizo Corporation, an OTC drug manufacturer in Kyoto, Japan, was cited for significant deficiencies during an FDA inspection. Observations included incomplete laboratory records due to undocumented repeated sample analyses, inadequate computer system controls with unreviewed audit trails for GC software, and insufficient laboratory controls regarding cleaning validation specifications and the use of un-evaluated customer laboratories. These issues indicate a lack of robust quality control and data integrity practices.