FDA Warning Letter for Chinese Contract Testing Laboratory

On 23 January 2025, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to the Center for Instrumental Analysis of China Pharmaceutical University following an inspection conducted from 18 to 20 September.

The firm is a contract testing laboratory that uses ¹H Nuclear Magnetic Resonance (NMR) spectroscopy to analyze active pharmaceutical ingredients (APIs) and intermediates for compliance with regulatory standards.

Key Violations Identified

The Warning Letter highlights significant Current Good Manufacturing Practice (CGMP) violations at the contract testing laboratory, including the following:

• Laboratory control records lacked complete data, proper documentation, and secondary review. For example, a specific test record of samples reviewed during the inspection contained only two lines of numbers with no explanation, headers, or titles. 
• Data was stored on external hard drives and could not be retrieved during the inspection.
• The NMR equipment was also used for academic teaching and research, and it was shared among multiple users without individual logins or access restrictions.
• Deviations and laboratory errors were not documented or investigated.
• The lack of a defined Quality Unit (QU) meant there was no oversight to ensure test accuracy, method validation, or compliance with regulatory requirements.
• The quality system was deemed inadequate in addressing CGMP compliance gaps.

During the inspection, the laboratory director stated that the firm is not involved in CGMP activities. However, this Warning Letter underscores that contract testing laboratories cannot exempt themselves from GMP compliance if customers use their data for CGMP purposes. When laboratory data is used for GMP-relevant decisions, the laboratory must adhere to GMP regulations.

FDA’s Actions and Next Steps

The FDA acknowledged the laboratory’s decision to cease drug testing services for the U.S. market. However, based on the nature of the deviations, the FDA strongly recommends engaging a consultant qualified to evaluate the firm's operations and assist in achieving CGMP compliance.

Failure to address these deviations may result in the FDA refusing admission of articles manufactured by customers whose products were tested at the Center for Instrumental Analysis of China Pharmaceutical University.

For further details, please see the complete Warning Letter on the FDA's website.