FDA 483 - Hubei JXBio Pharmaceutical Co., Ltd - August 30, 2024

An FDA inspection of Hubei JX Bio Pharmaceutical Co., Ltd. in Xianning, China, revealed significant deficiencies across quality, facility, and production operations. The firm was cited for inadequate personnel training and record-keeping, poorly established equipment cleaning procedures, and failure to assure in-process materials conform to specifications through proper testing. These observations highlight critical gaps in the company's quality management system.