FDA 483 - Wuhan Zonsen Medical Products Co., Ltd. - July 26, 2024

Wuhan Zonsen Medical Products Company Limited in Xinzhou District, Wuhan, Hubei, China, was cited for significant deficiencies in its manufacturing processes. Observations included inadequate laboratory controls, such as issues with product specifications, testing for objectionable organisms, and non-representative sampling. Additionally, the firm failed to store drug products under appropriate temperature and humidity conditions and did not properly identify in-process samples.