FDA 483 - Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. - September 10, 2019

An FDA inspection of Kyowa Pharmaceutical Co., Ltd.'s Second Tokushima Factory in Kawauchi-cho, Japan, identified significant deficiencies in environmental monitoring practices. The observations highlight inadequate procedures for air sampling, differential pressure monitoring, and surface sampling, alongside failures in investigating atypical environmental monitoring results. These issues indicate a lack of robust controls necessary to prevent potential contamination in drug manufacturing areas.