FDA 483 - Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. - March 22, 2024

The FDA inspected Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. in Tokushima, Japan, a manufacturer of drug products and sterile/non-sterile drug substances. The inspection revealed significant deficiencies in equipment cleaning, environmental monitoring for aseptic processing, adherence to sampling plans, raw material testing, and investigation of product discrepancies. These findings indicate a need for improved quality control and manufacturing practices to ensure drug product safety and quality.