FDA WARNING_LETTER - Center for Instrumental Analysis of China Pharmaceutical University - September 20, 2024

On January 23, 2025, the FDA issued a Warning Letter to the Center for Instrumental Analysis of China Pharmaceutical University, a contract testing laboratory, following an inspection from September 18-20, 2024. The inspection revealed significant deviations from Current Good Manufacturing Practice (CGMP) for active pharmaceutical ingredients (APIs), rendering the tested APIs adulterated.

Key violations included: 1. **Incomplete Laboratory Control Records:** The firm failed to maintain complete laboratory test records for APIs and intermediates, such as 1H Nuclear Magnetic Resonance (NMR) spectroscopy data. Records lacked essential details like sample preparation, test procedures, and system suitability. Not all records were second-person reviewed. Additionally, historical data stored on external hard drives was not readily available during the inspection. 2. **Inadequate Computerized System Controls:** Computerized systems for NMR equipment lacked adequate controls to prevent unauthorized access or changes, with multiple users sharing a single login ID with administrative access. 3. **Failure to Establish a Quality Unit (QU):** The firm lacked an established QU with defined responsibilities and procedures, and did not track deviations or laboratory errors, despite providing data for CGMP purposes.

The firm's September 23, 2024, response to the FDA 483 was deemed inadequate as new procedures lacked sufficient detail, and no retrospective review or risk assessment was conducted for past data integrity issues.