FDA 483 - Evonik Rexim (Nanning) Pharmaceutical Co. Ltd. - September 28, 2018

Evonik Rexim Nanning Pharmaceutical Co., Ltd. was inspected by the FDA from September 25-28, 2018. The inspection revealed significant deficiencies related to the qualification and monitoring of cold temperature storage, including a lack of temperature mapping, inadequate review of temperature excursion data, and failure to communicate temperature alarms to the Quality department for deviation initiation. These issues indicate a lack of control over critical storage conditions for temperature-labile reagents.