FDA WARNING_LETTER - Xian Libang Pharmaceutical Co., Ltd. - July 30, 2009

On January 28, 2010, the FDA issued a Warning Letter to Xian Libang Pharmaceutical Co., Ltd. following a July 27-30, 2009 inspection of their API manufacturing facility in ShanXi, China. The inspection revealed significant CGMP deviations, rendering their APIs adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations included: 1. **Failure of quality unit to ensure proper material testing and reporting:** The firm used one infrared (IR) spectrum for a raw material lot to release two subsequent lots, raising concerns about data integrity. Laboratory records lacked complete raw data. 2. **Failure of quality unit to ensure CGMP compliance and detect data manipulation:** The quality control unit failed to detect substituted IR spectra by an employee. The firm fired the chemist responsible and removed the previous quality control and quality managers, but the response lacked a comprehensive plan to ensure data integrity. 3. **Failure to have adequate controls to prevent raw data manipulation:** A laboratory analyst modified printed raw data for IR spectra. The firm's response to install a server by September 30, 2009, was deemed inadequate without details on system configuration, procedures, and qualification.

The FDA requires a comprehensive corrective action plan addressing data integrity, including training for all personnel, a retrospective review of all test results, and an assessment of the impact of