FDA 483 - Wuhan Zonsen Medical Products Co., Ltd. - July 26, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · f66dfc97-e103-43b0-a1bb-21184ad55a1d