FDA 483 - TriApex Laboratories Co., Ltd. - November 21, 2025

An FDA inspection of InApex Laboratories Co., Ltd, a nonclinical laboratory in Nanjing, China, revealed two significant observations. The firm was cited for inadequate equipment maintenance, specifically lacking documentation for routine cleaning and filter changes for cell incubators. Additionally, the quality assurance unit failed to accurately review a final study report, leading to discrepancies between reported results and raw data.