Center for Instrumental Analysis of China Pharmaceutical University

Warning LetterOpen

Mr. Wenbin Shen Director Center for Instrumental Analysis of China Pharmaceutical University No. 24 Tongjiaxing Road China Pharmaceutical University Nanjing Shi Jiangsu Sheng , 210009 ChinaFEI 3005037448Issued Jan 23, 2025Center for Drug Evaluation and Research (CDER)

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Letter Details

Firm: Center for Instrumental Analysis of China Pharmaceutical University
Location: Mr. Wenbin Shen Director Center for Instrumental Analysis of China Pharmaceutical University No. 24 Tongjiaxing Road China Pharmaceutical University Nanjing Shi Jiangsu Sheng , 210009 China
FEI Number: 3005037448
Country: China
Issue Date: January 23, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Center for Instrumental Analysis of China Pharmaceutical University, a contract testing laboratory in Nanjing, China, was cited for significant deviations from Current Good Manufacturing Practice (CGMP) standards for active pharmaceutical ingredients (APIs) during an FDA inspection conducted in September 2024. The facility failed to maintain complete laboratory control records for API and intermediate testing, including inadequate documentation of Nuclear Magnetic Resonance (NMR) spectroscopy analysis results, with test records containing only unexplained numerical data without headers or clarifying information. These deficiencies rendered the tested APIs adulterated under the Federal Food, Drug, and Cosmetic Act, as the company's methods, facilities, and controls did not ensure compliance with established specifications and standards.

Center for Instrumental Analysis of China Pharmaceutical University FDA Warning Letter, January 23, 2025