FDA 483 - Hisamitsu Pharmaceutical Co., Inc. - October 11, 2019

Hisamitsu Pharmaceutical Co., Inc. in Utsunomiya, Japan, a drug product manufacturer, was cited for significant deficiencies in its Quality Unit's oversight, laboratory controls, and manufacturing processes. The inspection revealed failures in thoroughly investigating discrepancies, conducting product recalls for OOS batches, adequately investigating customer complaints, and validating cleaning processes and analytical methods. These issues indicate a severe lack of adherence to current good manufacturing practices, potentially impacting drug product safety, efficacy, and quality.