TriApex Laboratories Co., Ltd – FDA 483, Nov 21, 2025

An FDA inspection conducted at TriApex Laboratories Co., Ltd, located in Nanjing, Jiangsu Province, China, on or before November 21, 2025, identified two significant observations documented on an FDA Form 483. The inspection was conducted under the authority of the Federal Food, Drug, and Cosmetic Act.

The first observation concerned inadequate inspection, cleaning, and maintenance of equipment. Specifically, for 2024 and 2025, there was a lack of documented routine cleaning and filter changes for cell incubators EQP-DL-148 and EQP-DL-149, which is a requirement of the company's own standard operating procedures.

The second critical observation highlighted a failure of the quality assurance unit to accurately review final study reports. A specific instance cited was in Study Number DT-2239-245, where the final report incorrectly stated that Subject 2003's red blood cell count was "basically lower than the intra-group average." However, the raw data indicated the count was actually higher than the group mean, demonstrating a discrepancy between reported results and raw data.

These observations require TriApex Laboratories to address the identified deficiencies, implement corrective actions, and potentially provide a written response to the FDA detailing their plans to ensure compliance with regulatory standards and their internal procedures.