Qilu SYNVA Pharmaceutical Co. Ltd – FDA 483, May 16, 2025

Qilu SYNVA Pharmaceutical Co., Ltd. in Dezhou, China, received a Form FDA 483 with five observations related to significant deficiencies in quality control, laboratory practices, and facility management. Issues included inadequate approval processes for product release, poor aseptic techniques during sterility testing, insufficient laboratory controls for smoke studies, non-representative raw material sampling, and improper identification of manufacturing equipment. These findings indicate a lack of robust quality systems and controls for API manufacturing.