FDA 483 - Aso Pharmaceutical Company, Ltd - September 08, 2023

Aso Pharmaceutical Company, Ltd. in Kikuchi-Gun, Japan, a contract manufacturer, received a Form FDA 483 with six observations. The inspection revealed significant deficiencies in laboratory controls, including a lack of specifications for impurities and microbial limits, and inadequate investigations into out-of-specification results and complaints. Other issues included undocumented deviations from procedures, insufficient process validation, poor facility maintenance, and a stability program that does not use the marketed container-closure system.