Jianerkang Medical Co., Ltd – FDA 483, Nov 1, 2019

An FDA inspection of Jiangsu Province Jianerkang Medical Dressing Co., LTD, a finished drug product manufacturer, revealed significant deficiencies in their laboratory control system and stability program. The firm failed to establish scientifically sound test procedures for drug product assays and had inadequate in-process sampling for microbiology testing. Additionally, their stability program lacked meaningful test methods, leading to a failure to demonstrate the purity of a drug product over its expiration period.