FDA 483 - Jilin Asymchem Laboratories Co., Ltd. - April 12, 2019

An FDA inspection of Jilin Asymchem Laboratories Co., Ltd in Dunhua, Jilin, China, revealed significant deficiencies across multiple areas. The firm's laboratory equipment qualifications and software validations were found inadequate, particularly concerning data integrity and investigation of system errors. Additionally, cleaning validation protocols were insufficient, and laboratory investigations were not adequately performed, indicating a lack of robust quality control systems.