FDA 483 - Hisamitsu Pharmaceutical Co., Inc. - May 31, 2019

Hisamitsu Pharmaceutical Co., Inc., a drug manufacturer in Tosu, Japan, was cited for significant deficiencies in quality control and laboratory procedures. Observations included failing to reject out-of-specification drug products, inadequate impurity testing, and a lack of written procedures for invalidating aborted tests. The firm also failed to review raw electronic analytical data prior to batch release for products distributed in the U.S.