FDA 483 - Tianjin Institute of Pharmaceutical Research New Drug Evaluation Co. Ltd - May 19, 2025

An FDA inspection of Tianjin Institute of Pharmaceutical Res. New Drug Eval. Co., Ltd, a nonclinical laboratory, revealed significant deficiencies across multiple areas. Observations included inadequate cleaning and sanitation of animal housing, poor facility maintenance, and failures in retaining reserve samples. Additionally, issues were noted with equipment maintenance records, accurate data recording, and adherence to standard operating procedures and study protocols.