FDA 483 - Tianjin Institute of Pharmaceutical Res. New Drug Eval. Co., Ltd - May 23, 2025

An FDA inspection of Tianjin Institute of Pharmaceutical Res, New Drug Eval, Co., Ltd, a nonclinical laboratory in Tianjin, China, was conducted from May 19-23, 2025. The inspection, directed to Dr. Jinfang Hu, Testing Facility Management, revealed multiple observations indicating non-compliance with regulatory expectations for nonclinical laboratory studies.

Key issues identified included inadequate cleaning and sanitization practices for animal cages and equipment, with clean items stored improperly and residual waste found in supposedly clean cages. The facility maintenance was deficient, evidenced by fecal matter in drains of clean animal rooms and floor damage. The company failed to retain required reserve samples of test and control articles for long-duration studies and maintained insufficient records for equipment maintenance, such as reagent replacement for tissue dehydrators. The study director did not ensure accurate recording and verification of experimental data, specifically clinical observation times. Additionally, written standard operating procedures (SOPs) lacked adequate detail for certain study methods, and changes to study protocols were not properly documented or approved.

These findings suggest a need for improved adherence to Good Laboratory Practices to ensure the quality and integrity of data. The company is expected to address these observations by implementing and documenting appropriate corrective actions.