FDA 483 - Changzhou Ruiming Pharmaceuticals Co. Ltd. - September 13, 2018

An FDA inspection of CHANGZHOU RUIMING PHARMACEUTICAL CO LTD revealed significant deficiencies in laboratory systems and equipment qualification. Issues included unavailable electronic records for QC testing, inadequate procedures for reviewing laboratory data and media suitability testing, and deficiencies in performance qualification and calibration of production equipment. These observations indicate a lack of control over critical manufacturing and quality control processes for active pharmaceutical ingredients.