FDA 483 - Wuhan Biocause Pharmaceutical Development Co., Ltd. - August 24, 2018

Wuhan Biocause Pharmaceutical Development Co., Ltd. in Wuhan, China, was inspected from August 20-24, 2018. The inspection revealed a significant issue regarding the improper storage of USP reference standards, which were not kept under recommended refrigerated conditions. This raises concerns about the suitability of these standards for use in qualifying working standards.