FDA 483 - Zhejiang Ruibang Laboratories Co., Ltd - October 25, 2024

Zhejiang Ruibang Laboratories in Wenzhou, China, was cited with four observations during an FDA inspection from October 21-25, 2024. The inspection revealed significant issues including inadequate investigation of out-of-specification results, unvalidated test methods, non-contemporaneous record-keeping, and a lack of written procedures for critical production processes. These findings indicate a need for improved quality control and documentation practices.